Supplier and External Manufacturing Expectations Manual

General Requirements

Introduction

Maker’s Pride is a leading manufacturer and co-packer of foods where food safety is a priority. Our suppliers are the critical link. This Supplier Expectations Manual is part of our effort to build a strong, long-lasting relationship with you. We believe that prioritizing the quality and safety of our products will fuel our mutual success as we continue to deliver excellence in every bite.

This manual applies to food-grade materials, ingredients, and food-contact packaging products. Suppliers are selected and retained based on their ability to provide sustained competitive advantage through excellence in quality assurance, safety, service, technology, and overall value. A clear understanding of, and commitment to, each of these criteria is required for a supplier to be recognized as a preferred business partner. Competitive pricing or service alone is insufficient if fundamental expectations in quality and safety are not consistently met.

The requirements and expectations outlined in this manual are intended to assist suppliers in achieving alignment with our organizational objectives. These standards have been established following a review of product defects, quality audits, and industry best practices. Effective implementation of these programs contributes to the prevention of product recalls, consumer complaints, rework, and operational downtime. Compliance with these expectations is a critical consideration in establishing and maintaining business relationships.

Suppliers are responsible for meeting or exceeding these minimum requirements to ensure that all products supplied are safe and conform to our quality and safety standards. Inquiries regarding these requirements should be directed to the appropriate procurement representative.

These expectations constitute minimum requirements and do not supersede or modify obligations set forth in contracts or product specifications. This manual does not provide instructions on establishing or managing food safety or quality systems; it identifies essential programs necessary to produce safe and consistent products. Suppliers are expected to leverage their expertise to implement these programs in a manner that ensures full compliance.

Certain requirements may evolve over time in response to changes in regulatory standards, scientific findings, or internal quality initiatives. Suppliers are expected to remain compliant with all applicable regulations and to incorporate updates as communicated.

Not all requirements may be applicable to every material, ingredient, or commodity. Exceptions may be considered based on product or process uniqueness.

Suppliers should consult their procurement representative regarding the process for requesting exceptions. Suppliers are evaluated based on multiple criteria, including the quality and completeness of food safety and quality documentation, system maturity and effectiveness, corrective action management, technical capability, delivery performance, corporate reputation, responsiveness, and communication. These factors collectively inform supplier approval and continued eligibility. Suppliers are also expected to foster a culture of continuous improvement, as it is integral to meeting and exceeding organizational expectations.

In the event of any conflict, inconsistency, or ambiguity between this Supplier Expectations Manual and any other document governing the relationship between Maker’s Pride and the Supplier, the documents shall control in the following order of precedence, unless expressly stated otherwise in a written agreement signed by authorized representatives of both parties: (i) the applicable master agreement, terms and conditions, or supply agreement between Maker’s Pride and the Supplier (including any amendments); (ii) applicable purchase order issued by Maker’s Pride (excluding any conflicting terms proposed by Supplier) (iii) applicable product specifications, quality agreements, or written specifications issued or approved by Maker’s Pride; (iv) this Supplier Expectations Manual; and (v) any acknowledgments, supplier policies, or other supplier-issued documents, all of which are expressly rejected and shall have no force unless expressly agreed to in writing by Maker’s Pride. This Manual establishes minimum operational, quality, and food safety expectations and is not intended to modify commercial terms, pricing, indemnification, limitation of liability, confidentiality obligations, or other legal or risk-allocation provisions, which remain governed by the applicable master agreement or terms and conditions or, in the absence of such agreements, the applicable Purchase Order issued b Maker’s Pride. Any deviations from or exceptions to this Manual must be mutually agreed in writing by Maker’s Pride and the Supplier and documented in a written amendment.

Brokers and Distributors

In cases where Materials are being procured through distributor and traders, the following requirements shall be followed:

Maker’s Pride is to be made aware of the identity of the product manufacturer.
The broker/distributor has a responsibility to ensure that the supplier complies with these requirements.
The broker/distributor shall notify Maker’s Pride of any manufacturing or supplier location changes in advance and must obtain approval from Maker’s Pride prior to change being implemented.
The broker/distributor shall demonstrate that traceability of products to manufacturing location level is maintained.
The broker/distributor shall provide Makers Pride the documentation to confirm supplier complies.
FSVP – if the broker or distributor is the importer on record, then they will be responsible for verifying foreign suppliers, conducting hazard analysis and maintaining records.
3PL Storage and Handling of Product – Brokers and Distributors may be required to sign an undertaking that they do not open or re-pack or re-label, or manufacture any materials stored in their warehouses.

Supplier Requirements

Suppliers shall be knowledgeable of and comply with the following:

All federal, local, country, regional and state regulatory requirements.
International regulatory requirements for ingredients, materials, and products being imported.
Religious and Identity Preserved requirements where appropriate (i.e. Organic, Kosher, Halal, Gluten Free, NonGMO, Vegan, RSPO, RFA, etc.)
Requirements pertaining to claims such as no r-BST, natural per Maker’s Pride specification.
Requirements as described in Maker’s Pride specifications
Suppliers shall ensure their suppliers are in conformance with the same requirements and ensure products are safe and conform to Maker’s Pride’s food safety and quality standards.

Supplier Evaluation and Approval

Each prospective supplier must undergo an evaluation prior to approval as a Maker’s Pride supplier. The purpose of this evaluation is to assess the prospective supplier’s programs and practices against the expectations found in this manual. Suppliers must complete all requested approval documentation detailing facility operations and necessary product details to allow Maker’s Pride to complete its Supplier Evaluation Form. Types of documentation includes, but is not limited to: QMS Assessment, Continuing Guarantee, Food Defense Form, Foreign Supplier Verification Form (if applicable), Supplier Hazard Analysis Form, Organic / Product Identity Statement, Country of Origin Statement, Proposition 65/ Heavy Metals Statement, and BPA Statement. Suppliers for products are encouraged to be certified to a current Global Food Safety Initiative (GFSI) standard. Suppliers who are certified shall provide their annual GFSI audit certificate and full audit report to Maker’s Pride for review. Suppliers must follow U.S. FDA current Good Manufacturing Practices (GMP), Title 21 CFR Part 117, FSMA and 9 CFR where applicable. Supplier documents must be submitted back to Maker’s Pride in TraceGains in timely manner. Upon review of all documents, an audit of the facility may be needed for specific products at each producing location. All decisions will be based on risk.

Supplier Classification

Approved: An “approved” supplier who has met all the requirements outlined in this manual and Maker’s Pride’s product specifications. Suppliers may have minor non-conformances (no food safety or critical quality non-conformances) that can be addressed by submitting a Corrective Actions, Preventive Actions (CAPA) plan response. The CAPA plan can be verified at the next planned audit.

Conditionally Approved: A “Conditionally Approved” supplier has met most of the requirements in this manual but require the development or implementation of CAPA plans to be approved. This status may also be used for suppliers who are pending additional documentation. Failure to meet the CAPA plan deadline or failing to provide satisfactory evidence of successful completion of CAPA plan can result in the supplier moving to “Not Approved” or “Disqualified” status.

Not Approved/Disqualified: A “Not Approved” or “Disqualified” has severe gaps in their food safety and/or quality programs. Suppliers who are assigned either status are not allowed to re-apply to supply Maker’s Pride until they submit a successful Corrective/Preventive Action plan and provide evidence of compliance with Maker’s Pride requirements outlined in this manual and in the relevant product specification. They will also be required to go through a full pre-approval audit. A supplier who becomes the subject of serious regulatory actions such as “Consent Decree” or suspension of registration by FDA or equivalent action will have their authorized status suspended until such time that Maker’s Pride can determine compliance and acceptability.

Qualification and Routine Audit

On-site audits performed by Maker’s Pride or a 3rd party auditing body may be required based on supplier risk. These audits are an evaluation of the supplier’s quality and food safety systems but focus on the supplier’s ability to meet requirements per this expectations manual. Qualifications audits are required for any supplier’s manufacturing location providing product to Maker’s Pride before the location can be fully approved to supply product. Routine audits are based on item and supplier risk as assigned by Maker’s Pride. High risk suppliers will be audited most frequently whereas medium risk suppliers will be audited every three years. Frequency may be adjusted based on individual supplier risk factors such as established history of audits, complaint history, food safety culture, etc. This will be determined by Maker’s Pride Corporate Quality. Audits will be 1-1.5 days depending on the size and complexity of the facility and its products. All suppliers will be required to submit corrective actions for all issues noted in this visit depending on criticality of finding (Critical = 24 hours, Major = 5 business days, Minor = 30 Days).

Confidentiality

The contracts between Maker’s Pride and the Supplier will govern the confidentiality of information shared by either company. A Maker’s Pride Auditor will not audit or inspect financial data, sales data or pricing data as part of the routine operational audits under this Manual. Auditors shall not be required to sign confidentiality agreements as a prerequisite to gain access for audits prior to or at any time during a food safety/quality audit. Maker’s Pride Auditors will not inspect personnel data, other than data relating to qualifications or training of technical and professional personnel performing functions pertinent to the audit. Contracted third-party auditors are not covered under this confidentiality agreement.

Change and Incident Management

Suppliers must have a program that assures appropriate and timely (a minimum of 90 days) communication of planned product changes to Maker’s Pride prior to implementation. Typical changes requiring communication are as follows but not limited to:

Product/ Service specification changes
Packaging changes (pack size changes, type of packaging, etc.)
Facility preventive control changes
New allergens introduced to previously approved production lines for product
Location changes (manufacturing and/or distribution locations)
Name change
Product formulation changes
Labeling

Noticiation to Maker’s Pride of Significant Events

Timely communication within the supply chain is critical to protecting food safety, quality, and product integrity. The Supplier must establish and maintain documented procedures to ensure that Maker’s Pride is notified immediately of any event that could affect the safety, quality, regulatory compliance, processing, or supply of Materials provided to Maker’s Pride.

The Supplier shall notify its Maker’s Pride Supply Chain and/or Procurement Representative immediately upon becoming aware of any of the following events, including but not limited to:

Discovery of a quality defect, process control deviation, or food safety issue that could result in a voluntary or involuntary recall or withdrawal of any ingredient or component supplied to Maker’s Pride, including but not limited to misbranded product or undeclared/unlabeled allergens in Materials.
Discovery of potentially defective or adulterated Materials associated with a Maker’s Pride product that is in distribution.
Identification of substitution, dilution, or replacement of any Material with an inferior, alternative, or unapproved ingredient. This includes, but is not limited to:
- Dilution or replacement of authentic substances with non-authentic substances
- Addition of illegal substances (e.g., Sudan dyes, Azo dyes, melamine)
- Physical or botanical substitutions
- Identification of food fraud vulnerabilities, economically motivated adulteration risks, or failed testing that could affect Materials supplied to Maker’s Pride.
Inadvertent release of any Materials from hold status.
Non-routine regulatory agency investigations, testing, sampling, reporting, enforcement actions, or any regulatory activity that may affect Materials supplied to Maker’s Pride. Routine inspections do not require notification unless:
- The inspection identifies noncompliance with applicable law that may impact Maker’s Pride product, or
- Regulatory sampling of product or Materials has occurred.
Any event that causes the Supplier to suspect that a non-conformance (including to specifications, contractual requirements, or applicable government regulations) exists in Materials already shipped to Maker’s Pride.
Failure of traceability or lot identification systems, or inability to complete a full forward and backward trace within required timeframes.
Product tampering, threat of tampering, or misrepresentation of ingredients or Materials.
A pathogen-positive test result in the Supplier’s facility or related to Materials, even if the specific lot was not shipped to Maker’s Pride. In such cases, both Maker’s Pride Quality and Procurement representatives must be notified.
Any event or substance that could threaten product security, including but not limited to unintentional contamination (e.g., radiation exposure) or natural disasters.
Notification by law enforcement or other authorities of a potential product security incident.
Changes to the Supplier’s processes and/or manufacturing location that could impact the safety, quality, regulatory status, or specifications of Materials supplied to Maker’s Pride.
Changes to formulation and/or allergen facility profile that could affect the labeling of a Maker’s Pride finished product. A profile change includes any change to allergen matrix management.
Inability to deliver Materials that meet Maker’s Pride specifications.
Loss, suspension, or withdrawal of GFSI certification at any of the Supplier’s manufacturing location

The supplier must notify Maker’s Pride by a phone call with a live person and by email. A voicemail, even coupled with an email is insufficient for notification. The Maker’s Pride Supply Chain/Procurement Representative shall be the primary contact for any contact or notification required by this Manual in addition to including [email protected] to all notifications. If there is a significant event at the facility that does not affect Maker’s Pride product – we shall be notified within 48 hours.

Essential Requirements

Regulatory Requirements

All food products shall be made with food grade ingredients. Food products shall be produced and shipped in compliance with applicable local, state, federal and international regulations.

All food ingredient manufacturing plants must be registered with FDA under the Food Safety Modernization Act (FSMA) except those solely under the jurisdiction of USDA-FSIS. Facilities must also comply with the biennial registration . The Bioterrorism Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the FDA. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack or hold food for human or animal consumption within the United States are also subject to the facility registration regulation.

Suppliers shall have written procedures that include designated personnel for regulatory contact and facility inspection. The facility shall maintain accurate records detailing regulatory agency visits and the resolution to all adverse findings documented by the regulatory agency. A hold and release program shall be in place for any product that has been sampled by regulatory or another entity for food safety or compliance testing on Maker’s Pride products until cleared in writing by the sampling agency and Maker’s Pride. Product placed on regulatory hold while in transit to Maker’s Pride must be communicated to Maker’s Pride Quality and Procurement immediately to ensure hold and clearance prior to use.

Maker’s Pride Quality and Procurement must be informed promptly of all such regulatory inspections of your facilities which involve the sampling of product. Such notifications shall also include occasions where the regulatory agency may ask to see shipping orders and shall confirm that specific shipments have been made to Maker’s Pride. In all cases, we would require having the lot numbers of products involved in either the actual sampling or the shipping orders that were examined.

When Maker’s Pride is purchasing imported products directly from a foreign supplier, supplier shall comply with all applicable US laws and regulations as well as those of regional governmental authorities that regulate the import of products. Such compliance activities can include, but not limited to, proper marking of the country of origin of goods, proper labeling, provision of all documentation requested or needed for compliance (such as country of origin certificates), complete product descriptions on invoice) and other compliance measures as required.

In the case of food ingredients, materials and Products that are purchased from a foreign source where Maker’s Pride is not the importer of record, the supplier is required to comply with the guidelines outlined under the Customs Trade Partnership Against Terrorism (CTPAT) program. All product imports shall comply with current U.S. food regulations as recently amended in the 2011 Food Safety Modernization Act (FSMA).

Traceability and Recall Requirements

Suppliers shall have a system in place to effectively identify and trace products. Traceability documentation/records shall meet all regulatory requirements for tracing forward and backward in the process.

Procedures shall be documented and implemented for identification of ingredients and packaging materials from receipt through production, including reworked product. Records shall be kept either on manufacturing check sheets or other suitable records and shall include specific information including plant lot/batch number, vendor name, vendor codes, and quantities used.

Product releases shall be in writing and can be sent electronically. Suppliers shall include the following information on their shipping records: product description, packaging configuration, Maker’s Pride product code, lot/batch number, pallet number(s), shipping location, quantities, and transporter information.

Suppliers must have a documented system for tracking and recalling product. Suppliers shall never initiate a recall of any product manufactured for Maker’s Pride without prior notification to Maker’s Pride and written direction from Maker’s Pride, with Maker’s Pride retaining sole authority over the initiation, scope, content, and timing of any recall, withdrawal, or market action as set forth in the applicable terms and conditions.

Traceability effectiveness of product must be routinely verified by conducting mock recalls. Suppliers shall complete this exercise at least annually or more often depending on plant performance and business requirements. Results of mock recalls shall be kept on file and made available to Maker’s Pride upon request. A summary of the mock recall exercise should include the following information at a minimum: product name and number, production date, lot number, total pounds produced, total pounds shipped to each storage or Maker’s Pride location with corresponding purchase order number, mass balance summary and reason for the recall.

The goal during any recall event, mock or actual, is to reconcile 100% of the finished product that was shipped against the quantity of product that was manufactured. If 100% effectiveness cannot be achieved, a root cause analysis shall be performed, and corrective actions implemented and verified. All actions must be documented.

Suppliers are required to report to the FDA through the Reportable Food Registry (RFR) and/or CFIA equivalent system if applicable – “nonconformances” that have gone “outside” of their control that would present a “Serious Adverse Health Consequence” or death, permanent injury or irreversible harm (i.e., Class I Recall). Suppliers shall notify Maker’s Pride Quality and Procurement of any RFR situation that involves the supply plant and line on which product was produced. This includes any RFR notification by the FDA or any regulatory agency working in concert with FDA.

Food Safety Program

Supplier products must be designed, produced and distributed using risk-based food safety programs to minimize food safety risks. Suppliers must have in place a written food safety plan for all products.

This plan must comply with the Preventive Controls for Human Foods rule and must be based on the following principles:

Documented hazard analysis detailing chemical (including radiological), physical and biological hazards
Identification of preventive controls, if needed
Established critical limits
Monitoring procedures
Defined corrections and corrective action procedures when critical limits are not met
Ongoing verification procedures
Established record-keeping and documentation procedures

Food safety programs shall be supported by a multi-disciplinary food safety team that meets on a regular basis, with minimum annual review and prior to any significant changes. Food safety plans shall describe the product, distribution and intended use. Maker’s Pride requires all suppliers to identify appropriate risk classification based on the intended use of their product. A flow diagram shall be developed to describe the process.

Food safety plans shall be validated by food safety team initially and prior to any significant changes. The hazard analysis shall include identification of hazards from product design, process and through consumption with detailed ingredient and process hazard analyses. Significant hazards likely to cause illness or injury in the absence of control shall be designated as Preventive Controls. Defined critical limits shall be established. Food safety plans shall include monitoring procedures with detailed steps, frequency, person performing the check and documentation as well as verification procedures to ensure the Food safety plan is being followed.

Documented corrective actions shall be in place to address deviation or loss of control at the Preventive Controls. This shall include root cause analysis, product risk assessment and disposition, and actions taken to regain control of deviated product. Food safety records shall be stored securely, easily retrievable and retained for the shelf life of product.

Physical Hazard and Extraneous Material Control

Suppliers shall have a documented physical hazard detection and control program including strategic placement of sifters, screens, magnets and metal detectors, xrays or vision systems at points in the process from the point of unloading throughout the process based on risk. Product protection devices shall be present, as appropriate, for the material category and product type. This would include the sifter, magnet and metal detector, ideally in that order. There shall be no further processing or handling between these final product protection devices and the end of the production line.

All physical hazard detection and control devices shall have an effective management program including:

Immediate response to findings
Investigation into source and root cause
Risk assessment for product produced
Complete documentation of checks and findings
Retention of foreign matter through shelf life of product

For screens, the mesh size of the screen shall be the smallest possible that is appropriate for the product. Screens shall be composed of a material that can be readily detected and identified by your system. Screens shall be inspected on a routine basis for integrity with consideration given to minimizing the amount of affected product and risk. Sifter tailings shall be examined regularly to identify potential extraneous material.

Magnets shall not be used to segregate or decontaminate known metal-contaminated ingredients or products. When used, magnets must cover 100% of the product flow and shall be tested for effective placement and coverage. Magnet strength shall be tested and documented at the time of installation and on a regular basis thereafter based on trending and processing parameters at minimum every 12 months. Magnet strength shall be consistent with the expected contamination. Magnets shall be inspected at a minimum of once per day to identify any contaminants. Magnets on bulk unloading systems shall be inspected after each vehicle/vessel is unloaded and/or based upon supplier’s acceptable level of risk.

Regarding metal detectors, test wands shall be passed through the metal detector at the same speed as the product and with the product flow. The frequency of testing shall be based upon the supplier’s acceptable level of risk in addition to at the start of production, end of production with a maximum of every 8 hours in between. The check shall validate the metal detectors successful rejection of the applicable stainless steel, ferrous and non-ferrous test pieces to verify both detection and timing. This includes that product in line with the test wand shall not be removed from the line prior to rejection to ensure that timing and rejection are appropriate. Verification of 100% effectiveness of the metal detector, its rejection mechanism, and/or related alarms, shall be conducted. All product used in the verification process must be rerun through the metal detector under normal circumstances or discarded once the verification is complete.

Metal detectors shall have an automatic reject or stop mechanism, along with an audio or visual alarm that must be acknowledged to clear. All rejects and alarms must be documented. Rejected product must be immediately segregated from the product stream and held separate from product rejected for any other reason. Rejected product shall be examined immediately upon rejection to permit identification and investigation into cause. All checks and findings shall be fully documented along with risk assessment and corrective action. Findings and documentation shall be retained for the shelf life of the product.

Metal detector set-up and effectiveness shall be confirmed by the manufacturer upon installation, when new product types are introduced and thereafter at least once annually. Detection levels must be based on the risk assessment and capability of the system.

Sifters may be substituted for metal detector as protection device by documented exception if the screen mesh size is of suitable size with increased frequency of checks to at least once per shift or supplier’s acceptable risk. Filters may not be used to screen out glass or glass-like (i.e., brittle plastic) material contamination in any product.

Suppliers shall have a documented glass and brittle plastic control program which shall include:

Usage of glass and brittle plastic shall not be allowed in the production area.
Light bulbs in production areas must be shatter-proof and must be covered and/or protected to prevent product contamination.
Full inventory and audit of glass and brittle plastic on a risk-based frequency, but no less than once every twelve months.
Supplier must have a procedure for handling breakage, which shall include segregation, product evaluation, clean up, documentation, corrective action, etc.

Allergen Control

Suppliers that provide Maker’s Pride with food ingredients and food contact chemical ingredients, shall develop and maintain an allergen management program that effectively controls the risks associated with the following allergenic or sensitizing ingredients. These ingredients have been identified by Codex and Maker’s Pride as major food allergens and ingredients of concern and shall be controlled and appropriately labeled, as required. All ingredient suppliers shall label all allergens (If applicable) in their ingredient or product composition declaration and have a system in place to verify the accuracy of labels and product information.

Allergens:

Peanuts and products thereof
Tree nuts (ex: pecan, almond, hazelnut)
Milk and milk products
Eggs and egg products
Soy and products thereof
Shellfish / crustaceans, mollusks and products thereof
Fish and fish products
Wheat and products thereof
Sesame and products thereof
Mustard and products thereof

Other substances that must be declared as ingredients in supplier products are:

Ingredients of Concern:

Gluten (non-wheat)
Celery and products thereof
Artificial coloring agents
Lupin and products thereof
Seeds (sunflower, poppy, etc.)
Buckwheat and products thereof
BHT/BHA/TBHQ
Sulphites (Sulfites)
Tocopherol (Vitamin E)
Bee pollen / Royal jelly
Nitrates / Nitrites
Corn and products thereof
Saccharin and/or Aspartame
Rice and products thereof
Beef Products
Monosodium Glutamate (MSG)
Pork and products thereof Hydrolyzed (autolyzed) yeast extract

Allergenic products shall be produced on a dedicated line running a specific allergen or allergen combination wherever possible. Allergen preventive controls must be established based on Supplier’s risk assessment and comply with FSMA Preventive Controls for Human Food. Production scheduling and allergen sequencing shall be used to minimize the risk of allergen cross contamination. Wherever possible, separation and physical barrier(s) shall be in place between lines and equipment running different allergenic products. As part of the segregation procedure supplier should include designated employee hygiene practices, uniforms, product and employee traffic patterns.

Storage practices shall be in place to prevent potential cross-contact of allergenic ingredients and materials. This shall include physical segregation, dedicated storage areas, unique labels and proper storage of allergenic materials.

At a minimum, the following practices must be in place (where applicable):

Allergenic ingredients must be stored from non-allergenic ingredients. Allergenic products must be stored
separately from non-allergenic products.
Allergens are to be stored with “like” allergens.
Allergens shall not to be stored above non-allergens.
Appropriate signage must be used in areas where allergens are stored.
Allergens must be stored in sealed, intact containers.

Product changeovers from one allergen to the next or to non-allergen products must be restricted to systems that have validated and documented cleaning and changeover procedures, which shall include verification of each cleaning. Process validations shall be completed every year. A cleaning checklist shall be utilized to identify, verify and document areas that have been cleaned. Each component shall be inspected to verify that it is visibly free of residual product build-up before subsequent production. A tool and container control program shall be in place to prevent cross-contact. This may include color coding, dedicated tools, cleaning practices, maintenance procedures, segregation and storage practices. Allergen contaminated materials shall not be reworked into product provided to Maker’s Pride regardless of reconditioning process.

A documented allergen training program shall be in place to educate all employees (personnel, temps, support staff, management, etc.) on the critical aspects of the major allergens and their risks shall be conducted at least yearly.

The overall allergen management program shall be reviewed for effectiveness every twelve months.

Biological Control

Where applicable, food ingredient suppliers shall have a biological control program in place with appropriate ingredient, environmental, processing and finished product controls. These controls shall be evaluated as part of the scientifically based food safety program, and with appropriate monitoring procedures in place. Products must conform to all applicable regulatory agencies’ microbiological requirements and be safe and suitable for food use in accordance with current Good Manufacturing Practices (GMP).

As part of the supplier food safety program, an ingredient hazard analysis must be conducted to identify microbiologically sensitive ingredients. Testing and/or COA verification procedures shall be in place to ensure safety of sensitive ingredients prior to use.

Kill steps included in the process shall be documented and supported by the appropriate validation, verification and ongoing monitoring procedures as part of the food safety program. The additional controls shall be implemented to minimize the risk of cross-contamination.

Environmental controls include, but are not limited to:

Effective hand washing and facilities for such
Effective footwear controls
Tools and utensils control
Control of traffic (personnel, materials, equipment, etc.)
Segregation of raw and post processed areas
Positive air flow from microbiologically sensitive areas
Additional controls for construction and other unique plant activities
Pre-established mitigation following an adverse event

All suppliers of food ingredient(s) shall have a biological control verification plan. The plan must have procedures for finished product testing which includes designated sample site(s), sample size, and frequency of testing that is to be conducted for each product and/or sample site, to be representative of the lot being tested. Tests to be conducted shall be documented and performed using standard test methods. If applicable, additional testing required by Maker’s Pride will be detailed in the approved ingredient specification. A positive release program shall be in place to ensure that no product is shipped until that product has cleared microbiological testing. Maker’s Pride does not accept re-test results as valid for finished product release to Maker’s Pride.

All microbiological testing shall be performed using standard test methods as approved by FDA BAM, AOAC or AACC. Testing shall be conducted at an accredited laboratory with procedures in place to validate and verify the accuracy of the results against Maker’s Pride approved specifications. Upon request, results shall be provided to Maker’s Pride.

All pathogen testing (via any method) MUST be conducted in a building which is SEPARATE from any building where manufacturing is taking place. Maker’s Pride preference is that the testing building is not located on the same property as where manufacturing is taking place. If pathogen testing is taking place in a separate facility but on the same property site, strict traffic controls must be in place to ensure there is no risk of contamination in the manufacturing site(s). Pathogen testing in the same facility as where production is taking place, will result in disqualification.

Hygienic Zoning

All suppliers that manufacture, or handle products shall have a zoning program in place to reduce the potential for microbiological contamination of products by preventing environmental cross-contamination though the application of proper controls. Zoning principles shall identify and differentiate processing areas within the facility where potential sources of pathogen and non-pathogen microbial contamination exist from air or traffic (e.g., people, equipment, and materials).

Suppliers should establish a written zoning program to include:

Identify potential sources of cross-contamination between processing areas and/or products (e.g., product handling areas, storage areas, processing areas, raw materials). Recognize that intermediate products may not have the same susceptibility as the finished product and during the manufacturing of a product the risk may increase from one step to the next. For example, the microbial contamination of a product before the kill step may not be as critical as its cross contamination after the kill step, and the controls applied to prevent contamination before the kill step may not be as stringent as the controls applied after the kill step.
Identify and implement appropriate controls for each zone, based on zoning risk assessment. Examples of such controls include physical measures or barriers, traffic management, utility controls, GMP measures, and sanitation controls.
Periodically evaluate and verify effectiveness and compliance of zoning requirements. This includes, but should be not limited to, environmental testing (including pathogen testing), GMP audits and routine pre-operational and operational inspections.

Environmental Monitoring

Pathogens represent a significant risk to products if not adequately controlled. Each supplier is required to have a routine monitoring process for environmental contamination as part of its biological control effectiveness verification. An effective monitoring program, focused on pathogens of concern, reduces the risk of contamination in finished products. The environmental monitoring program shall take a “seek and destroy” approach and be rigorous enough to detect and identify microbiological contamination in the facility environment. When contamination is discovered, appropriate containment measures and corrective actions to control and eliminate the contamination shall be implemented. These must be further verified for effectiveness.

The environmental monitoring program shall be documented and include:

Facility and product specific plans that identifies target organisms and indicator organisms.
Minimum requirement will be to test for Salmonella spp. and Listeria genus.
Documented sampling procedure by trained personnel.
Use of standard test methods, such as AOAC, BAM, ISO, IDF, Codex etc.
Identification of required sampling sites based on historical data and relevant risk.
Detailed description and zone designation for all sites sampled.
Process to respond to positives including investigation, immediate swabbing, usage of vectoring technique, cleaning and ongoing monitoring until at least three consecutive daily negative results are achieved.
Risk analysis and increased surveillance due to unique plant events such as construction or adverse events.
A documented minimum annual program review, including target organisms and sites sampled.

For suppliers that choose to composite samples, procedures shall be put in place to ensure only samples for like zones and areas of the plant are composited to aid in the investigational response to a positive pathogen test.

Additional controls shall be put in place for any pathogen testing on food contact surfaces with consideration for validated cleaning procedures, clean breaks, hold and release program and a process to respond to positive pathogen test results.

Maker’s Pride defines 4 different areas/zones for sampling the environment, as described below:

Zone 1 – Direct product contact surfaces and areas that can result in direct or indirect contamination during equipment operation and all surfaces from which liquids may drain, drop, diffuse, or be drawn into the product or into the container and thus NOT included in environmental monitoring. This includes, but is not limited to pipeline interiors, conveyors, product storage vessels, fillers, product contact hands, worktables, grinders, slicers, and shredders. Examples of zone 1 are: utensils, conveyors, people, etc.
Zone 2 – Non-product contact surface areas near product contact surfaces or where product is exposed to the environment. Examples include equipment panels, aprons, etc.
Zone 3 – Non-product contact areas further removed from product contact surface areas and product is enclosed. These are areas that could not be contaminated without mechanical or human intervention. Examples include table legs, floors, drains in processing areas, etc.
Zone 4 – Non-product contact areas outside the processing areas. Examples include doorways, walls, drains in nonprocessing areas.

Environmental sampling for Listeria genus and Salmonella species is qualitative. The purpose of the testing is to determine presence or absence of these organisms. Environmental sampling for indicator organisms (excluding Listeria genus) is quantitative. The purpose of testing is enumeration of those organisms (e.g., Coliforms and/or Enterobacteriaceae). Indicator organisms tend to indicate unsanitary conditions within the facility.

Site specific sampling locations shall reflect the most critical locations and are dependent upon such criteria as the product being produced, equipment design, plant structure, traffic patterns, and previous findings. Sampling locations shall not include raw, unprocessed materials and raw processing areas (e.g., unpasteurized milk and cream). Walls and floor drains located in relevant areas shall be included in any sampling plan. Routine sampling must take place during production, at least 3 hours after start-up. The time frame for taking swabs (e.g., shift, midweek, end of week) should be changed on a periodic basis. Swab site locations should be audited and changed on a periodic basis. The results must enable a clear correlation to the sampling point. Sampling must be conducted at least 3 hours into production. Trend analysis of positive/out-of-specification findings shall be conducted to detect areas of concern.

Whenever results exceed or trend toward the specified limits, root cause and corrective actions must be taken and documented. If out-of-specification results are obtained, swabs must be repeated to ensure the corrective action was effective prior to operation. If swabs locations are rotated, swab testing should be repeated until three consecutive acceptable results are achieved in the “out of specification” location. Corrective action plans shall address the root cause of the contamination issue and include mechanisms to verify the effectiveness of corrective actions. For example, corrective action may include improved cleaning or sanitation, redesign of the structure or equipment, improved GMPs, or redefined traffic patterns. The implicated and specific test site locations shall be re-evaluated to verify the effectiveness of corrective actions. Corrective action must be initiated immediately and must be completed in timely manner.

Cleaning, Sanitation & Sanitary Design

Suppliers shall have an adequate and documented cleaning program in place to cover all cleaning procedures. Program shall include verification and validation components to ensure effectiveness of the cleaning procedures. Suppliers shall have implemented a written sanitation program that ensures cleanliness of the food processing environment, equipment (including inbound and outbound tankers/trailers) and tools. The program shall address:

Sanitation schedules, methods, and frequencies
Correct use of appropriate sanitation equipment and tools
Equipment disassembly and re-assembly frequencies
Verification of sanitation effectiveness including microbial validation
Non-pathogen environmental monitoring programs
Inspection procedures
Recordkeeping,
Corrective action determination

Written sanitation instructions shall include (where applicable):

Chemicals to be used, how they are to be used including chemical concentrations, contact time, temperatures, frequencies, and rinsing procedures, if applicable.
Clean In Place/Clean Out of Place (CIP/COP) steps
Manual cleaning instructions

Proper tools and materials must be used to prevent extraneous matter, microbiological and/or chemical contamination of the product. Items that are known to be potential sources of contamination must be prohibited- loose bristles, removeable parts, easily damaged and breakable. Brushes and utensils for cleaning food contact surfaces shall be clearly identified (e.g., labeled and/or color coded) and properly stored in designated areas and separated from non-food contact tools. Floor drain cleaning brushes and equipment shall be clearly identified as such and maintained separately from other cleaning equipment. Drain cleaning equipment must be stored securely and have limited/restricted access to them.

Utilities Management (Water, Steam, Air)

Supplier shall have implemented programs to ensure safe provision of all utility services in production areas. These include water, steam, and environmental air. Supplier shall also control access points for the above referenced utility services, as well as electricity, heating, and ventilation. Access can be controlled by any means that the supplier deems effective, such as locked facilities which only authorized employees can open.

An adequate supply of potable water with appropriate facilities for storage, distribution and temperature control shall be available (whenever necessary) to assure safety and suitability for food. Potable water shall meet the requirements as specified in the US EPA National Primary Drinking Water Regulations, the latest edition of World Health Organization Guidelines for Drinking Water Quality or equivalent regional/country/state/local standard. All potable water systems must be protected against backflow (anti-siphonage) from potentially non-potable water, e.g. chemical dosing equipment, CIP/COP systems and product vessels. Backflow (anti-siphonage) devices shall be tested. Non-potable water (for use in fire control, steam production (non-food contact), refrigeration, and other similar purposes where it would not be exposed to/used in food) shall have a separate system. Non-potable water systems shall be identified and shall not connect with, or allow siphonage into, potable water systems.

Water used as an ingredient, processing aid, reclaim water, hand wash water, for brine solutions and as sanitation final rinse shall be tested by a qualified and certified laboratory. Recirculated water must be treated and/or filtered and tested at a designated frequency to verify potability. Supplier must have programs in place to test water at point of use with established testing frequencies based on risk assessment.

Water used as an ingredient, processing aid, reclaim water, hand wash water, for brine solutions and as sanitation final rinse shall be tested for total plate count (TPC) and coliforms (including re-circulated cooling water). Disinfection (e.g., chlorination, ozonation, UV light) of surface and well (ground) water is required for all direct product uses (e.g., ingredient, sanitation, rinse, drinking) and indirect product uses (e.g., re-circulated cooling water, hand wash). Residual chlorine and ozone must be periodically tested, and corrective actions shall be taken when levels do not meet required limits.

The extraneous matter risk in all incoming water needs to be controlled using filters. Filtration systems (e.g., charcoal, reverse osmosis) shall be regularly inspected and maintained. Water systems must not have cross-connections between treated and untreated supplies. Incoming water lines must be fitted with one-way valves or equivalent.

For surface or well water sources, a visual turbidity assessment shall be carried out daily. Incoming well water must pass through an extraneous matter filter (200 mesh/75 micron or smaller). When alternate filtration methods are used (e.g., sand filtration, reverse osmosis), they must be shown to be equivalent to that of 200 mesh/ 75-micron filtration. Testing shall also be carried out following any event which may adversely affect turbidity, such as abnormally heavy rain or flooding.

Steam which is introduced into food or used to clean food contact surfaces or equipment shall be treated and/or filtered in such a way that food is not contaminated with unlawful, indirect additives or contaminants. All additives must be approved by the FDA and comply with regulation 21 CFR 173.310. Steam shall be of the appropriate quality and purity to meet process and usage needs. Boiler chemicals, solvents, cleaning agents and other chemicals must be approved for food use and if not in immediate use, must be stored in locked areas with controlled access.

The method for supplying air under pressure, which comes in to contact with ingredient, product or any product contact surfaces must be designed to provide sanitary air to the process that complies with the 3-A Accepted Practices for Supply Air Under Pressure. If non-food grade oil is used in the compressor, the frequency of preventive maintenance must be increased to weekly or more frequent to assure filter integrity. Pressure differentials may be used as a nonintrusive means of testing filter integrity.

There shall be adequate heating, ventilation or air conditioning for all rooms and compartments to permit maintenance of sanitary conditions. Air system equipment shall be designed, installed and maintained to prevent any additional contamination to food and food contact surfaces. Air that comes in to contact with food or food contact surfaces, must be properly filtered. All process air for conveying, cooling or direct product contact shall be filtered through a (HEPA) high efficiency particulate filter with a MERV (minimum efficiency reporting value) rating of 15 (EU F9 rating) or higher.

Good Manufacturing Practices and Risk Basked Manufacturing Controls

All Products must comply with the U.S. Federal Food, Drug, and Cosmetic Act of 1938 as amended and the U.S. FDA Food Safety Modernization Act. All products shall be processed and packed under strict sanitary conditions in accordance with U.S. FDA current Good Manufacturing Practices (GMP), Title 21 CFR Part 117.

Suppliers must develop and implement an effective, documented program to ensure regulatory compliance, food safety and sanitary conditions of the facility which shall include:

The facility’s grounds and exterior structure shall be designed and maintained to provide protection from environmental elements, pest entry and harborage.
All openings providing exterior or interior access to the facility shall always be properly sealed and/or screened.
The facility’s roof shall be accessible and well maintained.
Interior structures shall be designed and maintained to be impervious and cleanable.
Facility shall be maintained to be free from loose paint, rust and/or other debris that may contaminate product zones.
Water leakage and/or condensation shall be controlled to prevent product contamination or microbiological hazards.
Traffic patterns of people, machines, and materials throughout the facility and grounds shall be controlled to prevent contamination.
Hand wash stations shall be adequately located and maintained in good repair.
Any post lethality and RTE processes direct product handling must use gloves.

Suppliers shall have equipment designed and maintained to prevent product contamination. This includes but is not limited to an effective preventive and corrective maintenance program. Additionally, procedures shall be in place to ensure adequate tool controls, as well as appropriate cleaning and sanitizing of tools prior to production. In the event temporary repairs are necessary, they shall be documented and managed effectively. Lubricants shall be designated for their specific use and adequately controlled, and a calibration program shall be in place for all sensitive equipment.

Training and education programs shall be in place. Health policies shall be in effect to prevent spread of infectious or communicable diseases. Employees shall have a clear understanding of general hygiene practices and uniforms and protective gear requirements. Employees shall be compliant with documented personnel practices and food safety requirements.

Suppliers shall have waste materials properly identified and adequately controlled. Packaging and raw materials shall be received, stored and used to prevent contamination. There shall be at minimum an 18” perimeter maintained around the warehouse and storage areas. Product shall be a minimum of 6” off the floor. Appropriate storage conditions shall be maintained to ensure and maintain material integrity. Storage surfaces and racking systems shall be clean and in good condition. Raw materials and finished goods shall be stored separately.

A documented chemical control program shall also be in place which includes an approved chemical list, inventory control process, chemical preparation and usage. A system must be in place to control chemical hazards including:

SDS and technical data sheets must be maintained and be made available for all chemicals used in the plant.
Controls must be in place to segregate chemical storage from production and food storage areas.
All primary and secondary (e.g. spray bottles) containers must be clearly labeled as to its contents to prevent misuse. All containers must be placed back into storage after use.
Chemicals must be used as designated by the label.
Chemicals must be stored with controlled access. All containers shall be labeled properly.
Chemical stock must be rotated to ensure they are utilized within its labeled shelf life.
Only food grade lubricants may be used in areas which are exposed to food or food contact surfaces.
Boiler and water treatment chemicals must be approved for use with food product.

Rework Control

Suppliers shall have a system in place to control the use of rework materials in any products while maintaining traceability. Undeclared ingredients may not be added to a product in the form of rework, regrind or other means. Rework material is permitted only at levels deemed safe (free of pathogens, residues, non-declared allergens and foreign material, etc.), of identical formulation and does not affect quality and performance of the product.

Product formulas and procedures shall have specific provisions regarding the use of rework material. These provisions shall include:

Amount of rework material to be used
Acceptance criteria
Conditions of storage
Reprocessing steps
Identification of allergens
Restriction to use in identical products
Age limitations
Special handling requirements
Lot number identification for traceability

All rework material shall be identified and segregated as appropriate. Microbiologically sensitive rework material shall receive a validated “kill step” prior to or during the rework process. If a “kill step” is not used, the product to which the rework material was added must be microbiologically tested following the rework process. Pathogen contaminated materials shall not be reworked into any product regardless of the reconditioning process.

Corrective Preventative Action for Complaints and Continuous Improvement

Suppliers shall have a system in place to address complaints made by Maker’s Pride through corrective and preventive actions. In addition, suppliers will also adhere to a continuous improvement plan to ensure the greatest level of both safety and quality.

Suppliers shall have a documented process for the management of corrective actions and longer-term preventive actions when failures of any part of the quality or food safety system occur. When system failures lead to a non-conformance with Maker’s Pride’s approved specifications, manual requirements and expectations, regulatory requirements or internal process control criteria, a root cause analysis shall be conducted. Corrective actions shall be taken to prevent like situations from recurring. Preventive measures shall be designed and implemented to ensure long-term correction of the identified deficiency.

Non-conformance notifications (complaints) from Maker’s Pride must be addressed in a timely manner. Food safety related complaints be addressed within 3 calendar days. All other complaints must be addressed within 14 business days. Records shall be maintained. Periodic evaluation of trends shall lead to appropriate preventive action.

Suppliers are expected to establish, document, and maintain food safety and quality management systems and continually improve their effectiveness. Action plans for continuous improvement are to address issues related to:

Key Performance Indicators (i.e., conformance to specifications, percentage of first pass quality, consumer and customer complaints, etc.)
Product yield losses, process efficiency opportunities, etc.
Customer service (on-time shipments and other service-related issues)
Audits (internal and external quality audit results)

Training

Suppliers shall have a planned, functional, and effective training program for all personnel including but not limited to full time, seasonal, part-time, temporary, and contractors. Training shall include, but not be limited to the following: food safety, chemical control, allergen control, food hygiene, sanitation, calibration, testing practices, internal auditing, regulatory requirements, maintenance, food defense, and GMP practices. Training records shall be maintained and retained. Records shall include a list of participants with signatures, date of training, training content and participant comprehension evaluations. Refresher training shall be conducted at least every 12 months and when processes or procedures are changed.

Supplier Quality Assurance Program

Suppliers shall have a documented risk-based supplier quality assurance program compliant with preventive controls for human foods that assures the quality and safety of all products and conformance to approved specifications and all applicable government regulations. Typical program requirements include but are not limited to:

New Vendors – Risk based approval process, addressing food safety concerns
Current Vendors – On-going maintenance process
Written specifications for all ingredients and materials
Letters of Continuing Guarantees (or equivalent) on file
Approved supplier list that restricts the purchase and receipt of ingredients and materials from only those suppliers contained on the list
Non-compliance management program
Ingredient and material receiving procedures

Product Process Control and Labelling

Suppliers must have a specification control program in place that includes clear accountabilities, document control and verification procedures to ensure the correct Maker’s Pride specifications are being used. Procedures shall be in place to obtain approval from Maker’s Pride prior to making any changes to product, process, specifications, formulas and producing locations. A process control plan shall be in place, along with a sampling plan and quality attribute testing to ensure product is produced to agreed-upon specifications. A label control program shall be in place to ensure product labels accurately contain all required information. A label verification program shall be in place to ensure the correct product is packaged in the approved package with the approved label. As part of the label control program at minimum, there shall be procedures in place that: ensure labels and pre-printed packaging are stored in a manner that reduces mixing with other labels. Food contact packaging shall be wrapped or covered and not exposed to the environment Suppliers shall provide Maker’s Pride with a list and declaration of country of origin for all the individual raw ingredients and materials used in the formulation of the product(s) supplied to Maker’s Pride. Ingredient labeling program shall be in place to ensure all products meet the below label requirements. Each unit (bag, drum, box, etc.) shall be identified with the following information clearly legible at 15 feet:

Supplier material name and number
The lot number preceded by “Lot”
The date of manufacture in the format of MM/DD/YY, preceded by “MFG” or another clearly distinguishable label for manufacture date
The date of expiration in the format of MM/DD/YY, preceded by “EXP” or another clearly distinguishable label for expiration date
The name of the manufacturer
The manufacturing location
The net weight
The ingredient’s declaration of contents (ingredient statement)
The Kosher or Halal symbol or any other appropriate regulatory labeling

When the units are palletized, they shall be positioned so that the supplier ingredient/item number, lot number, date of manufacture and expiration date are readable from at least two adjacent sides (four sides preferred). Maker’s Pride will only accept ONE lot per pallet and no more than THREE lots per shipment. Metal clips shall not be used for closing the units, nor shall metal or plastic ties be used for closing bags within the unit. Package liners must be manufactured according to “food grade” specifications and of a color that is easily distinguishable from the product packaged in it. Poly liners must conform to the food additive order in 21 CFR 177.1520. All Products shipped on wooden pallets shall meet the following requirements:

A corrugated/fiber slip sheet shall be used to prevent product and wood contact as well as aid in the transfer of the material from the wooden pallet.
The wooden pallet shall conform to the NWPCA standard for 48” x 40” #1 hardwood pallets. Including but not limited to:
1. 7 top deck boards
2. 5 bottom deck boards
3. Full length stringers without repair or cracks
The corrugated/fiber slip sheet shall conform to the following requirements:
1. 52” x 44” (L x W)
2. 05” thick
3. Scored on two adjacent sides 4” from the edge

Shelf Life

Shelf life and storage requirements (product’s life span from date of manufacture and storage conditions under which product is to be stored) shall be established for all products. Supplier is responsible for the accurate testing and validation to determine recommended ingredient shelf life and storage conditions. Alternate storage conditions can change the shelf life and are reflected in our specification when appropriate. Product should be shipped immediately after approval/release where feasible. Unless otherwise agreed, product must be received with at least 50% shelf life remaining. If less than 50% of its shelf life remains, the product may be rejected or returned unless preapproved by Maker’s Pride Quality prior to shipment.

Storage

Suppliers shall store products in a manner effectively preventing contamination (direct or environmental) and degradation. If third-party storage/warehouse facilities (i.e., dry storage, freezer, cooler, etc.) are used by supplier, the facility may be subject to Maker’s Pride approval and may include an inspection by either a representative from Maker’s Pride or from a Maker’s Pride approved third-party auditor. Such facilities must have all the appropriate controls and documentation in place to meet the requirements as described in this manual. Requirements for warehouses include:

Annual food safety audit verified by the supplier
Temperature and humidity controls, if/when applicable
First In/First Out (FIFO) or First Expired/First Out (FEFO)
Proper storage of Product off floors and away from walls
Segregation of food/non-food/raw/cooked products
Segregation of hazardous materials from food
Segregation of aromatic material
Fire control program
Regulatory inspection, as required

All products are to be shipped in accordance with Maker’s Pride transportation guidelines, FSMA sanitary transport rules
and the instructions listed in the Maker’s Pride approved specification.

Certificate of Analysis (Coa)

Suppliers shall ensure that product will not be shipped to a Maker’s Pride facility until the supplier has completed all required testing and verified that the ingredient meets all requirements of both this manual and Maker’s Pride approved specification. The items to be tested and documented on the COA shall be listed in the Maker’s Pride approved specification. ANY AND ALL EXCEPTIONS to these requirements are subject to prior approval by Maker’s Pride Corporate Quality.

Each COA shall identify the manufacturer, manufacturing address, the Maker’s Pride ingredient name and number, date of manufacture and the testing results by lot number. All COAs must arrive with or be at the Maker’s Pride receiving plant’s attention prior to receiving the ingredient in question.

Hold and Release Controls

Suppliers shall have effective documented controls in place to prevent the inadvertent shipment of non-conforming products to Maker’s Pride. Withheld or rejected products shall not be shipped to Maker’s Pride. The hold and release program applies to product on the supplier’s premises or in third-party facilities used by the supplier.

All suppliers must have:

A documented hold and release program that effectively identifies, prevents inadvertent movement of, isolates, and maintains control for any substandard or non-conforming products due to potential quality or food safety issues and/or are waiting for testing results
An effective disposition process that ensures only authorized personnel disposition held products, the disposition instructions are followed, and documentation is maintained
A procedure for placing suspected non-conforming products immediately on hold upon discovery
Documented procedures outlining responsibility for communicating information between internal and external parties (including Maker’s Pride)
Inventory reconciliation procedures capable of verifying proper control
The supplier must maintain records sufficient to enable reconstruction of each hold event (e.g., quantities, code dates, lot numbers, product numbers, reasons for hold and/or release, investigative information, disposition, and traceability information).
Some examples of holds include, but are not limited to the following:
1. Undeclared allergens or undeclared sensitizing agents (i.e., sulfites, MSG, etc.) identified in product
2. Failure to meet preventive controls requirements
3. Failure to meet specified legal requirements
4. Contamination due to employee illness
5. Unacceptable pathogen test result
6. Presence of an undeclared ingredient
7. Product undergoing pathogen testing
8. Foreign material issue
9. Defective product (quality hold)

Each pallet or container shall be identified as “ON HOLD” or words to that effect. The method used for identification (tags, stickers, signs, electronic hold, etc.) shall be used only for withheld products. Products on hold for food safety concerns shall be placed in a dedicated or segregated storage area. Each pallet or container shall be “physically” identified as “ON HOLD” or words to that effect when on food safety hold. An audit of the hold and release program shall be conducted at least once every 12 months.

When delivery commitments are at risk of not being met, a process shall be in place to immediately notify Maker’s Pride Procurement. If products are inadvertently or improperly released from hold status, Maker’s Pride Quality and Procurement must be immediately notified.

Documented authorization shall be required for all disposition actions. Disposition shall be determined and completed in a timely manner. Records shall be kept and include the product affected, date of production, number of units, date of destruction, and signature of the responsible person and witness. Product disposals shall be conducted according to applicable regulatory requirements. Product designated for destruction shall be handled in a way to assure proper defacement and disposal so that it cannot enter the stream of commerce or be available for consumption. Procedures for destruction shall include confirmation requirements, especially for food safety issues.

Food Defense

Suppliers shall have plans/programs in place that will ensure proper protection of products. Each facility shall have a written food defense and plant security plan. In addition, each facility shall conduct and document an assessment to determine potential gaps and perform audits to evaluate effectiveness of security controls.

Minimum requirements for incoming materials should include:

Security controls at suppliers
Use of tamper evident features for ingredients and materials
Review of records of previous products transported in tankers, railcars, shipping containers, etc.
Institution of food security programs to address potential risks on the farm
Security of off-site facilities, warehouses, controlled atmosphere storage, etc.
Procedures for handling deliveries (i.e., instructions for truck drivers and delivery personnel)
Use of seals to secure shipments (verify seal numbers match bills of lading)

Minimum requirements for the outside premises should include:

Limit facility access to authorized personnel only
Identify outside boundaries to control access
Physical measures (fences, gates, etc.) and perimeter security in place to prevent unauthorized access (24 hours per day, 7 days a week)
Identify all structures and their contents
Adequacy of outside lighting
Use of surveillance tools (cameras, etc.) to monitor premises
Increased monitoring in areas of higher concern (outside storage tanks for cleaning chemicals, coolant, ingredients, etc.)
Defined responsibility and authority for monitoring and controlling access
Procedures in place for investigating any food security situations
Inspection of incoming transport vehicles for possible contamination
Assessment and control of entrances to the facility which shall include those not normally used as a point of entry (i.e., escape doors, equipment room entrances, windows, heating/air conditioning duct entrances, trash ducts, water treatment, etc.)

Minimum requirements inside the premises should include:

Limit facility access to authorized personnel only
Self-locking access doors
Procedures for investigating any food security situations inside the plant
Program for identification and segregation of restricted areas in the plant
Access of contractors in the facility limited to areas relevant to their work
Programs to prevent security breaches (i.e., control panels, air circulation lines, electrical boxes, gas or pressure valves, etc.)
Potential for certain equipment to be clandestinely accessed for the purpose of introducing a contaminant
Plan that identifies all areas where products, ingredients and materials are handled and stored (warehouses, refrigerated coolers and freezers, controlled atmosphere storage facilities)
Monitoring and inspection of lines that handle water, syrup, oil, bulk ingredients, etc.
Security of computer software and hardware that document and control food processing, accessed by authorized personnel utilizing password protection
Security practices to prevent any compromise of information technology, data storage systems, and servers
Procedures and/or physical barriers in place to restrict access to hazardous compounds (i.e., pesticides, cleaning and sanitizing chemicals, etc.)

Minimum requirements regarding employees, applicants and visitors should include:

Controlled facility access restricted for applicants
Company-issued identification badges to identify employees, visitors and contractors
Background/verification checks
Training program for employees, emergency procedures, reporting of suspicious situations and/or wrongdoing, product tampering, etc.
Recruitment practices of temporary agencies and outside hiring sources conform to all requirements of the Manual.
Restrictions on leaving facility during normal work hours
Procedures and restrictions on visitors

Food Fraud

Suppliers shall have a food fraud/intentional adulteration program in place that is FSMA and GFSI Compliant. At a minimum this program shall include:

A vulnerability assessment of all ingredients used at the site.
An annual review of the assessment conducted using relevant information such as www.transparency.org, FDA recall notifications, and other information and sources deemed pertinent.
A mitigation plan developed and implemented where vulnerabilities are determined.
Suppliers shall maintain an Organic Fraud Prevention Plan that meets the requirements of the USDA Strengthening Organic Enforcement (SOE) regulation, including verification of the organic status and integrity of all incoming organic ingredients.

Equipment Calibration Program

Suppliers shall have a documented program to ensure that laboratory, maintenance, analytical, and processing equipment calibrated. The program shall meet all regulatory and industry requirements. Suppliers shall identify each piece of equipment that is critical (equipment affecting quality and product safety), and determine calibration requirements, frequency and responsibility. Calibration or maintenance frequency is determined based on the critical nature of the measurement, history of calibrations, and/or equipment supplier recommendations. Critical test equipment is to be calibrated using certified or other acceptable industry standards. A corrective action process shall be in place if equipment is determined to be out of calibration.

Previous lots of product shall be re-evaluated for conformance to specifications and critical limit measurements, and nonconforming products shall be held. Instructions for calibration of equipment must be documented if the work is done internally. Records of calibration for critical monitoring equipment (control points) and corrective actions are to be made and maintained. A review of critical calibrations must be undertaken by a qualified reviewer within the week in which they occur. This allows for timely action to be taken in the event equipment is found to be out of tolerance.

Record Requirements

Suppliers shall maintain records for three years, for twice the time period equivalent to the shelf life of the product, or as required by federal, regional, country, state, or local regulations, whichever is the greater time period. All records for products shall be available for review during audits or inspections by Maker’s Pride representatives. Records shall be stored in a secure area, shall be easily retrievable and must relate to all critical process safety and quality monitoring points in the manufacturing, storage and distribution of the products. Retrievability of records shall also be tested and documented during mock recall exercises.

Retain Samples

Suppliers are required to retain samples of the product(s) produced. Samples shall be representative of the production run and stored up to the shelf life of the product.

Pest Control Program

A documented pest control program shall be in place to effectively prevent pest activity in the facility and surrounding area. This program shall be managed and executed by trained, licensed plant personnel and/or approved outside contractors. Only certified Pest Control Operators (PCO) or personnel with equivalent training shall perform pest control activities.

Rodent traps, insect electrocution devices, and other pest/insect devices in product manufacturing or storage areas shall be serviced at regular intervals and as activity warrants. Bait stations shall be kept outside of the manufacturing and storage buildings the placement of pest/insect devices shall be in such a way as not to present a contamination risk to products, packaging, or processing equipment. The locations of pest/insect devices shall be documented and charted to concentrate on potentially high activity areas (trash docks, pallet storage, etc.). Use of all pesticides (insecticides, fungicides, rodenticides, and fumigants) shall be in accordance with current laws and regulations of the location in which Products are produced and the destination to which products may be delivered.

Only licensed or certified PCOs or employees under the supervision thereof may apply pesticides. Certifications shall be maintained in accordance with state and regulatory requirements in which the pesticides are applied.

Pest Control Program records shall include:

Any observed evidence of pest activity in the facility (i.e., insects, rodent droppings, trap and/or bait station activity, etc.)
Chemicals used
Safety Data Sheet (SDS) information for all chemicals used and samples of labels
Areas treated
Quantities and concentrations of chemicals used
EPA or other appropriate registration number
Person(s) applying chemical
Pest control operator license (with expiration date, certification and training details) and proof of insurance
Maps for insect light traps (ILT), interior traps and exterior traps
Trends on pest activities must be documented with corrective actions.

Transportation and Shipping Expectations

Supplier is solely responsible for the sanitary condition and acceptability of the vehicle when loaded and will ensure compliance with Maker’s Pride specifications and FSMA Sanitary Transport Rules, regardless of the origin of the vehicle or any previous cleaning conducted.

All products are expected to be stored and shipped in a manner to provide adequate protection from potential physical, chemical, or biological hazards. In addition, all shipments shall have a tamper evident seal(s). All seals must have a unique identification number which must be documented on the Bill of Lading. Maker’s Pride will not accept product if the seal number(s) on the shipping vehicle does not match the seal number(s) listed on the Bill of Lading. Maker’s Pride requires that ONLY a Maker’s Pride Receiving employee can break a seal. If any seal is broken prior to that point, the product will be rejected.

The container in which the product is shipped shall not derogate the quality of the product. Food products shall be conveyed to Maker’s Pride facilities only by carriers who can assure that their vehicles (truck, tanker, rail car, ocean going vessels, etc.) are suitable for handling food products and ingredients (edible items from the GRAS list, Food Additives List, or basic food stuffs) prior to loading. Under no circumstance, can a vehicle that has previously hauled contaminated or potentially unsafe material (including, but not limited to, garbage, trash, asbestos or toxic, infectious or medical waste) be utilized for hauling food products. Documentation showing the nature of the last three shipments (or more if required by Maker’s Pride for tanker trucks must be made available.

Supplier shall perform and document a thorough inspection of the carriers prior to loading to assure all required safety and sanitation criteria are met. This includes cleaning residual materials and potential contaminants from the cleaning and unloading hoses carried on the vehicle. All vehicles shall be free from the evidence of rodents, insects, birds, dirt, rust, scale, oil, grease, mold, metal, glass, rigid plastic, objectionable odors, blood, toxic chemical residues, cleaning material residues and all other types of foreign material. Each vehicle shall be sound in structure and in good repair. The walls and floor shall be free of splintering wood and have tight fitting hatches (if equipped) and doors. Vehicles must be washed in an approved manner as often as necessary to keep them free from buildup and foreign material contamination. Interior of vehicles must be dry prior to loading.

Vehicles used for liquid products (tanker trucks, rail cars) must be washed and sanitized appropriately before each shipment and restricted to carry only food grade materials. All trailers must have a document wash ticket. The wash certificate (or copy) must be made available to Maker’s Pride from the drivers for inspection. The wash ticket shall contain the name of the product transported just prior to the wash. Kosher wash tickets if applicable must meet Kosher wash requirements. Carriers provided by Maker’s Pride shall meet the requirements in MP.2009 Expectation Manual for Transportation Carriers.

Document and Data Control

Suppliers shall establish and maintain documented procedures to control and secure all documents and data that relate to ingredients, materials, production, processing and finished products. This includes, but is not limited to, Food Safety programs, label approvals, standard operating procedures, manuals, product testing results and quality records. When documents, such as formulas, procedures, Bill of Materials (BOMs) and specifications are received from Maker’s Pride, the suppliers shall: return any acknowledgements and/or certifications, ensure access to these documents is secured and restricted to authorized personnel who are covered under a confidentiality agreement, and also not disseminate these documents to any outside recipients. Invalid or obsolete documents (except those retained for legal and/or knowledgepreservation purposes) are promptly removed from all points of issue or use. Those retained should be suitably identified.

Crisis Response and Business Continuity

Supplier shall have a multi-disciplinary team in place to manage situations involving food safety, quality, and regulatory issues, including plans to manage product recall and retrieval activities. Roles and responsibilities, including decision making authority, shall be well defined and documented. Supplier shall have a documented plan in place for the recovery from either a partial or complete interruption of critical functions due to an unforeseen event. A mock crisis drill shall be performed at least once every 12 months.