NCAs Good Manufacturing Practices (GMPs) Best Practice Guidance Based on the Codex Alimentarius General Principles of Food Hygiene Introduction In an effort to support its member companies and the confectionery industry, the National Confectioners Association has established a training program consisting of a number of courses on food safety and quality topics. The first of these courses is a basic course in Food Safety and Quality that encompasses GMPs, and is based on the Codex Alimentarius General Principles of Food Hygiene. The intent is to clearly present all required elements that would be necessary to consistently produce safe, quality products for the confectionery market. In this document, the elements considered for each area of food safety and quality will be compared to the requirements imposed upon the manufacturing confectioner in various audits (such as BRC, SQF, SAFE, etc.), as well as by FDA and other regulatory agencies. In some cases, it will be a customers requirement for the manufacturing confectioner to contract with a third party auditor to confirm to them that all quality and food safety controls are in place. Although this practice is often quite costly, such audits are extremely valuable. The confectioner can develop an internal audit program with a system to implement corrective actions that respond to issues observed by both the internal and external audits. The combination of internal and external audits is a powerful way to verify that all quality and food safety programs are operating as the company expects. Each course in the NCA Food Safety educational series will take a pipeline approach considering all steps in the product life cycle (food chain). The courses will begin with product design and development, continue through the factory conversion, and finish at the point of consumption. The training will take into consideration the various types of confectionery processing including chocolate, sugar confections, and gum, and will accordingly identify specific areas of risk with respect to quality and food safety. Participants will take away a clear understanding of hazard identification, risk mitigation, and process controls to assure quality and safety are implemented using a HACCP - based Quality Management Program underpinned with the appropriate prerequisite programs. SECTION #1; R&D Objectives: The product development process is the first stage in the product life cycle. A documented Risk Assessment (RA) protocol must be integrated into the R&D process. The RA procedures must be applied not only for new items in the concept phase of development, but also for changes made to existing products and processes. It is important to introduce HACCP at the product development stage, and to make R&D associates responsible for hazard evaluation and definition of process controls. There are critical quality and food safety elements that must be considered in the product design

phase in order to prevent issues further down the pipeline. Definitions:

Food hygiene: all conditions and measures necessary to ensure the safety and suitability of food at all stages of the product life cycle. Hazard: a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. HACCP: a system that identifies evaluates and controls hazards which are significant for food safety. R&D: the product development process is responsible for creation of new food products, processes and packages, and for modifications to existing formulae, manufacturing processes and packages. Specifications: any criteria with which product, process, services, or other activity must conform.

1.1: Ingredients; consider the impact of raw materials on the facilities planned for manufacturing the new/changed products. Understand the potential sources for the raw material supply. KEY considerations will be microbiological criteria (raw foods vs. processed), allergens, foreign objects and the size of particulates. 1.2: Process and Packaging; new products may be made on a bench-top or in a pilot plant. Good Manufacturing Practices must apply if the products made are intended for consumption. Scale up from early development stages will require the application of food safety and quality prerequisite programs for process development in the facilities which will produce the items. A hazard analysis must be conducted to assure proper fit for the products in the process environment and on the equipment designated for use in production. KEY considerations will be equipment cleanability, the location of the equipment, traffic control for ingredients and operators, and air handling systems. 1.3: Systems and Specifications; The R&D process must be supported by some basic systems. For smaller businesses, these may not need to be highly sophisticated, but they must be in place and operating effectively. KEY considerations will be a Risk Assessment procedure, a procurement process for acquiring raw materials and packaging, a specifications system for raw materials, packaging and finished product recipes/formulae, and a customer/consumer feedback system for managing compliments and complaints and making product improvements. A product and materials tracking system will also be expected SECTION # 2: MATERIAL QUALITY MANAGEMENT Objectives: The purpose of Material Quality Management is to assure that all supplied

raw materials, packaging, and contract services for material delivery consistently provide safe product and a quality level that meets the company's purchasing specifications. Manufacturing confectioners typically use a range of materials that can vary from simple to complex, and high risk (critical) to low risk (non-critical). The material risk assessments must be done by the confectionery processor as part of their GMP program. Since we are supporting a HACCP approach, it is within the HACCP context that the confectionery processor should define the risks and qualify Critical Control Points (CCPs), both at the vendor, and within their own processes. It is well known that most confectionery operations have very few CCPs in their own processes; for the most part they receive and blend ingredients to manufacture their finished products. Therefore, all prerequisite programs (PRPs) are critically important to their operations; one key PRP is the Supplier Assurance program. This program incorporates inspection and audit of the suppliers process. The first step is to be sure all material/service specifications clearly document all quality and food safety requirements. The program will build a strong relationship with suppliers to provide a conduit for communications of any issues and process changes. The material risk assessments must include documentation of all handling activities for raw material receiving including sampling, testing, and segregation during storage and handling to maintain material integrity, and procedures for proper management of non-conforming materials. Definitions:

Supplier Assurance a program used to approve material suppliers, and to assure their continuing ability to deliver products that meet company specifications Root Cause Analysis drill down capability for troubleshooting the source of a quality problem, with the intent of implementing a sustainable resolution Corrective Actions an action prescribed with a commitment to follow through in a defined time period to resolve an observed quality problem Preventative Actions an action prescribed with a commitment to follow through in a defined period of time to avoid an observed quality problem Certificate of Analysis (COA) - a document issued by the supplier at the request of the receiving site (purchaser) which contains analytical test results for critical raw material/packaging material specification parameters

Specifics for Confectionery Products: Microbiological: (indicator organisms); aerobic plate count, coliforms, Enterobacteriaceae, yeast & mold, fecal streptococci, E. coli, S. aureus Microbiological: (pathogens); Salmonella, Listeria Chemicals: food allergens, heavy metals (e.g., lead, cadmium), pesticide residues, aflatoxin and other mycotoxins, residual sanitation chemicals

Physical: wood, glass, plastic, metal, stones, natural foreign materials (e.g., seeds, shells, twigs) 2.1: Material Sourcing: Consider the impact of raw materials within facility. KEY considerations will be microbiological criteria (raw foods vs. processed), food allergens, foreign objects and the size of particulates. Understand the potential sources for cross contamination in the raw material supply and transportation; storage temperature and humidity conditions; separation of major food allergenic components which may imply the potential need for a label coding system to identify allergen categories; raw materials separated from finished products; raw material segregation. The agricultural commodities may have special requirements (e.g, peanuts with aflatoxin; dairy with antibiotics). Sourcing of materials is critical. Therefore, when sourcing a material the confectioner will need to consider all areas targeted for procurement. Specifications are a mandatory part of the basic GMP process for raw materials and packaging. Specifications need to cover all critical food safety areas including HACCP, and identified hazards involved in specific raw materials. They should include transportation requirements, storage conditions, spec. ranges for acceptable transportation of product,and any other product safety concerns. 2.2: Supplier Assurance and audits: The manufacturing confectioner needs to have a Supplier Assurance program. Supplier audits should be conducted according to the critical nature of the material. For example, dairy suppliers may need to be audited twice per year; while sugar suppliers can be audited every other year (provided nothing changes in their process). The supplier audits should consist of a thorough review of the food safety management programs and confirm that the companys specifications are understood and accepted. 2.3: Control of non-conforming materials: Incoming raw materials considered rejectable should be clearly identified with an appropriate label and quarantined within a designated area. To mitigate the root cause and make disposition on the material, the ability to trust the supplier and maintaining an open relationship will be critical. As appropriate, corrective and preventative actions in addition to root cause analysis need to be applied to sustain resolution to those issues. 2.4: Special consideration for imported materials: For some manufacturing confectionery purposes, international purchases from Asia/China may be necessary when no domestic sourcing is available. This may include both packaging and raw materials. In these situations, an international visit may not be possible, however, it will be critical to utilize a third party audit program to review Quality and Food Safety practices. The use of these materials may be under regulatory scrutiny for emerging quality and/or food safety issues (e.g. melamine, lead, formaldehyde, BPA in plastic, pesticide residues). Regardless of the size of the confectionery business, the manufacturer will be accountable for the materials that are received and converted to marketed products.

SECTION # 3: PERSONAL HYGIENE Objectives: In this area of GMPs, the manufacturing confectioner is concerned with people. The area of personal hygiene is typically what comes to mind when GMPs are discussed. Although the requirements are very basic and rationalized by good "common sense", they must be consistently enforced for all plant operators, contractors, visitors, and anyone that enters the factory environment, especially for those who contact the product. The personal hygiene program is based on the premise that people are primarily aware that their actions can (and will) impact the quality and food safety of the confectionery products they are making. Thus, it is their responsibility to strictly adhere to the GMP rules provided by the company. As a matter of course, the confectioner must hire people that understand this responsibility, and regularly make GMP - personal hygiene training available for all to attend. This section also covers items in place for personal protection of all operators, visitors, contractors, and others in the plant environment, such that their own safety will not be compromised. Definitions: Good Manufacturing Practices (GMPs): a set of requirements for food manufacturers designed to guarantee product safety and quality. In the U.S., the Code of the Federal Register (CFR 21, Part 110) documents GMPs as the food manufacturing laws originally given in the Federal Food, Drug, and Cosmetic Act 1) Product contact zones: surface areas of food process equipment that actually make

contact with product while it is being produced

3.1: Personal practices and GMPs: A high degree of personal cleanliness must be maintained to prevent contamination of confectionery products. All employees, contractors, visitors, etc are expected to maintain good personal hygiene. A neat and orderly appearance should be maintained while at work.

3.1.1.1 Handwashing: Anyone working in a process area must wash and sanitize his/her hands before starting work, upon returning to the work area, after each visit to the restroom facilities, or any time the hands have become soiled or contaminated. Handwashing signs need to be posted, at minimum, in all restroom facilities, locker rooms, break areas, etc.

3.1.1.1.1 An appropriate handwashing method requires warm water,

approved soaps, proper length of time (15 sec minimum), disposable towels, and approved hand sanitizers when required.

3.1.1.2 Glove use: Only approved gloves should be used for handling

products and/or product contact surfaces. Gloves must be

maintained in-tact and stored in a clean and sanitary condition. If gloves become unsanitary, they should be replaced or re-sanitized. The use of latex gloves is not recommended. Cotton gloves should not be worn when touching exposed product.

3.1.1.3 Uniforms and footwear: Employees who work in process areas

should only wear company approved clothing and footwear (including safety shoes if required). Footwear should be clean, neat, in good repair, and ideally worn and stored in the facility. In areas where potential exists for direct contact between the product and uniforms, disposable (or company issued) aprons are recommended.

3.1.1.4 Hair restraint, beard restraint, bump caps, and other head gear:

3.1.1.4.1 Company supplied hair restraints must be worn in process

areas. If caps, hats, bump caps are used, they must be worn over top of hair restraints.

3.1.1.4.2 Employees must be clean shaven or cover the exposed hair

with a company supplied beard restraint. Provided they are neat and properly trimmed, side burns and mustaches are permissible.

3.1.1.4.3 In general, barrettes, hair pins, combs, and other hair

ornamentation are not recommended. Plain elastic hair bands, bandannas, scarves are acceptable if worn under company supplied hair restraint.

3.1.1.5 Personal protective equipment: In designated process areas, metal

detectable ear protection is recommended. Ear protection should be secured to prevent contamination. Safety glasses and/or side shields may be required in certain process areas. Hard hats/construction headgear may also be necessary in construction areas. Depending on specific manufacturing conditions, other personal protective equipment may be required (i.e. thick aprons, gloves, steel tip boots, etc)

3.1.1.6 Personal items: Jewelry, watches, medications, personal items such

as bags, purses, and newspapers, are not permitted in processing areas. Badges, tags, pens, pencils and thermometers may be used provided they are stored below the waistline and are securely attached.

3.1.1.6.1 Body piercings are acceptable only in areas that can be fully

protected by company issued uniforms.

3.1.1.7 Food containment: Food and drink may not be consumed in

processing areas and must be properly stored in designated areas. Smoking, chewing gum and/or consuming confectionery samples is permitted only in designated areas. Alcoholic beverages are prohibited from the plant sites.

3.2 Health related situations: In general, it is recommended that only healthy

associates work in processing areas. The company should provide associates with guidelines around communicable diseases. Operators with minor cuts and wounds should cover them with a metal detectable band aid. If skin conditions and/or wound can not be properly contained, the employee cannot work in a processing area

3.3 Visitors and contractors - The company must provide GMP and safety

guidelines for all visitors to the facility (may include lab coats, jumpsuits, protective footwear, safety equipment, etc). Facility tours should proceed from the finished product area back to the raw material area to minimize risk of contamination. Any type of contractors working in the processing area should abide by the same GMP rules as regular employees. Contractors involved in construction activity must refrain from entering food processing areas unless they also abide by the process area GMPs.

3.4 Associate training All new hires must receive GMP training as part of an

orientation training package. GMP training must be renewed at least annually for existing employees. It is recommended that in-house training modules be prepared and include pictures with dos and donts specific to site needs, equipment, facility, and line of products. Facilities that contain allergens may have specific training needs to highlight separation and dedication of certain areas such as line areas, traffic patterns for material movement, etc. Therefore, it is recommended that specific allergen training modules also be administered at the same frequency.

SECTION # 4: FACILITIES AND EQUIPMENT Objectives: The control of the confectionery process site is critical to protect the integrity of the products being manufactured. In this area of GMP, control begins with the site location and the plant design; these will combine to determine the degree of difficulty involved in protecting the operation from the "elements", pest intrusion, and other adverse impacts from the environment. There are basic food plant best practices for floors, walls, ceilings, windows, doors, drainage, and other infrastructure to which the site should adhere. Each confectionery manufacturer should maintain their own "clean design manual" for reference to these best practices. Using this approach, they can enforce engineers and others making modifications to the site to focus on the company's GMPs. Lighting and air handling are critical elements for

plant environmental controls and promotion of food safety and quality in production. Provision of water and steam needs to be from acceptable sources which need to be checked on a regular basis. Storage areas for materials and for finished goods must be controlled as well as the actual production areas of the facility, including all areas through which materials travel during the manufacturing process. All manufacturing equipment must be designed to deliver the intended level of product quality and prevention of food safety issues. The equipment must be placed such that it is accessible for proper maintenance and sanitation, including any product sampling and inspection that may be required. As is discussed throughout the GMP Best Practices, many types of confectionery manufacturing equipment will be dry cleaned, and present a different set of challenges for product safety and integrity. A preventive maintenance schedule must be in place to avoid quality and food safety issues from degradation/wear or drift in performance, and to promote calibration and effective operation. All non-process areas of the site should be concerned with compliance to GMPs as well, such as locker rooms, cafeterias, maintenance shops, and company stores. Waste materials, including effluent, and all affiliated handling and disposal practices need to be controlled to avoid and adverse impact to production areas. Definitions:

ATP adenosine tri-phosphate; a rapid test used as an index of sanitation for equipment surfaces; residual cell debris reacts with the compound to yield results correlating to sanitation effectiveness; a number of kits are commercially available CIP - clean in place systems are used throughout the food industry for closed systems like storage tanks/silos and the flow line circuits that deliver and remove food products. The systems typically run a wash, rinse, and sanitation cycle to thoroughly clean and sanitize the product contact surfaces of the tanks and lines. COP, clean out of place, is a similar cleaning and sanitation operation using wash tanks. Change control a discipline involving a rigorous process to monitor and manage all changes to product and process in a food operation. Change control applies to new product start ups as well as to any modifications to existing recipes and the equipment/facilities used to produce them.

Specifics for Confectionery Products: Dry environments; many raw materials and process areas must be maintained dry. The introduction of moisture can promote microbial growth, and result in possible product contamination. Dry cleaning; to maintain a dry process environment, and equipment product contact surfaces, dry cleaning may be a requirement. This is typical for the chocolate process, where certain equipment (e.g., enrobing systems, tempering units) may not be cleaned at all.

Isolation of critical process areas: raw product areas handling materials like raw peanuts, raw cocoa beans, flour/raw dough, must be considered microbiologically contaminated. These areas must be totally separate from process areas handling the roasted/cooked materials (finished products). SSOP; ( standard sanitation operating procedure ); a controlled procedure for cleaning and sanitizing an area of the site or a piece of process equipment. 4.1: Environmental controls are part of the GMP program covering the plant facility. The site environment typically refers to all product and material handling areas, and the external plant that could impact the operations areas.

4.1.1 Exterior plant requirements for GMP controls include roof integrity,

vegetation around the facility, proper isolation of trash receptacles, restricted areas for eating and smoking, and perimeter precautions that cover security ( Food Defense ).

4.1.2 Interior plant requirements for GMP controls include provision of

adequate storage temperatures and humidity, adequate lighting, control of air handling/HVAC systems, isolation of non-food areas for chemical storage and maintenance activity, water and waste water control with back flow prevention devices as required.

4.1.3 Special areas for GMP requirements include locker rooms, cafeterias, rest

rooms, and break areas. Some of these areas and other handwashing stations must be adequately supplied with soap, warm water, and disposable paper towels. There should be proper signage to assure all operators, contractors and visitors wash their hands as given in the GMP requirements. Since all confectionery facilities are different, the number and placement of hand wash stations will vary.

4.2 Pest management for confectionery operations is usually managed on an external, contract basis due to the certifications/licenses required for storage and handling of pesticides. The pest control program must be effective to comply with GMPs. To accomplish this it is recommended that the confectionery manufacturer train an internal resource to closely monitor the contract pest management service. The company is ultimately accountable for any pest issues that may arise and for the chemical applications performed on the site. All of the activity must be properly documented with records of site visits and verification audits. In general an 18 inch perimeter is required throughout the facility for access to clean and inspect all equipment and operations areas.

4.2.1 Exterior requirements for effective pest management include bait stations and trap spacing and locations around exterior of facility; bird control such as netting and sound devices if necessary, and properly contained trash receptacles.

4.2.1.1 GMP controls need to account for any risks associated with pallets,

unclean trailers, railcars, construction materials, or any issues from neighboring buildings. If there is a need to store pallets outside of the factory, there must be a cleaning and inspection requirement to protect the process areas.

4.2.2 Interior requirements for effective pest management include the use of

control devices compatible with food processing.

4.2.2.1 GMPs permit the use of glue boards, tin cats, etc. for rodent control. Trap spacing and locations in the interior of the facility should be mapped and monitored for effectiveness.

4.2.2.2 GMPs permit the use of UV light traps and pheromone traps in

certain areas to prevent and monitor insect presence. Some of the insects that may be found in confectionery operations include Indian meal moths, merchant grain beetles, fruit flies, ants, cockroaches, spiders, and silverfish.

4.2.2.2.1 An area that can often be a challenge for confectionery plants

is where floor drains provide wet environments for insect breeding. These must be regularly monitored and cleaned/treated as necessary.

4.2.3 To effectively manage the pest control program, all areas of the site

need to be included: storage areas for all materials ( even office supplies ), cafeterias, locker rooms, break rooms, maintenance shops, laboratories, and food storage carts

4.3: Cleaning and sanitation is a GMP requirement for all food processors. The challenges for most confectioners come with the application of both wet and dry cleaning methods in the same facility. Containment of the moisture generated by wet cleaning is critical to maintaining a microbiologically safe environment, and a clear understanding of the cleaning procedures is a critical requirement for operators.

4.3.1 Good housekeeping in the confectionery plant sets the stage for

proper cleaning. GMPs require that all daily/on-going activities include expectations for a clean working environment. Many plants use a structured approach that instruct operators to put all things in their appropriate place, such as hand tools on marked storage racks; all change parts stored appropriately; hanging brooms/mops/utensils in dedicated areas of use; neat desk areas/computer stations, etc.

4.3.2 Cleaning and sanitation GMPs require proper storage of all chemicals used for cleaning and sanitation of equipment and environments; solvents, caustics, sanitizers etc.; whether the materials are supplied in small spray cans or large drums. MSDS sheets are required as part of plant safety programs, along with employee training for all of those participating in cleaning and sanitation activities. A master sanitation schedule should be completed to dictate daily, weekly, and monthly requirements, and when to clean and sanitize areas and equipment before and after product runs. A rigorous schedule must be in place to manage plant shut down activities. CIP and COP system procedures, hand cleaning methods, mold washing and storage, dry clean procedures, should all be clearly documented work instructions, and be accessible references for operators.

4.3.2.1 Dry Cleaning is commonly used in many chocolate

making/handling operations. Chocolate enrobers, kettles, tempering units, conches, storage vessels, and associated lines/pumps are seldom wet washed due to the risk on microbiological contamination that could come from residual moisture. Some of the equipment is typically not cleaned. The product in the equipment is usually run down to a minimum level, and equipment is scraped and sometimes covered with plastic to protect product contact surfaces and prevent environmental contamination. Pumps, lines, and all closed units/systems are usually simply left in tact with little/no heat applied during down time. Some cooling /conditioning tunnels are also not designed for wet cleaning; for these systems belts are usually cleaned locally by bucket and brush rather than hosing them, again to avoid water that cannot be completely dried/removed. The same dry clean disciplines are typically applied to confectionery packaging areas/rooms which have exposed electrical controls equipment, scales, bucket conveyors, metal detectors, etc. As with other dry clean procedures, water with appropriate cleaners and sanitizers may be used to wipe down product contact surfaces; but the solutions are applied very locally, and removed quickly to assure the absence of residual moisture.

4.3.2.2 Wet cleaning is appropriate in many confectionery

operating environments and for many types of confectionery equipment. Many plants are equipped with dairy tiles and rooms that can be completely hosed

down; but it is important to refrain from taking this approach in areas that connect to dry clean areas of the site. Wet cleaned equipment is designed to be bathed in appropriate solution of cleaners and sanitizers; the KEY component is that ALL moisture can be removed prior to restarting the equipment. CIP systems, for example in a caramel cooking system, are thoroughly contained, and the cleaning and sanitizing solutions are injected and circulated for specific amounts of time. It must be part of SSOP procedure to periodically verify CIP operations, such as chemical pumps, spray balls, circuit pressure, etc. These can trap particulates, and redeposit food debris on what is expected to be a cleaned surface.

4.3.3 Testing and verifications for cleaning and sanitation are important

activities required for the GMP program. Some programs use equipment swabs where product contact surfaces are checked for microbiological indicator organism counts. Many programs require pathogen checks in the various plant environments. ATP swabbing can be performed using commercial kits designed to conduct rapid verification checks. Allergen swabbing may be a requirement for certain changeover practices. It is important to note that even before verification is done, the cleaning and sanitation procedure must be validated. Only a validated procedure can be verified for its effectiveness.

4.4: Maintenance: GMPs are required for maintenance personnel and for all related activities. The repair and installation of equipment will impact the confectionery process areas of the site, and care must be taken to prevent contamination from exposing product to an adverse environment, or from lubricants and other items used to maintain process equipment.

4.4.1 Tools and tool carts may need to be dedicated for

microbiological control and/or allergen management. For example, if the plant does baking and handles raw flour, the tools may be contaminated with pathogenic microorganisms. The same would be true for raw peanut processing in a confectionery plant. For GMPs, appropriate guidelines need to be in place for cleaning and sanitation of tools and tool carts that are not dedicated to specific areas of the plant.

4.4.2 External contractors on site to perform maintenance activities

must adhere to the same GMP requirements as site associates. So, for construction activity involving new equipment installation, plumbing, welding, etc.; there must be strict

guidelines documented to prevent cross contact with foreign materials, even odors, which could compromise product quality and safety.

4.4.3 As for cleaning and sanitation, maintenance of all sanitation

equipment such as spray balls, valves, etc. is critical for confirming the effectiveness of the operations. GMPs require a preventative maintenance process to be in place where, similar to the master sanitation schedule, there are PMs for equipment and areas to anticipate maintenance needs. An important element for maintenance activity is calibration; for metering devices, scales, temperature controls, air controls, etc.

4.5 Change Control is critical to the confectionery operation, especially in the area of cleaning, sanitation, and maintenance. Any time modifications to processing equipment or a plant environment are made, the operators ability to access equipment for effective maintenance cleaning/sanitizing could be compromised. Change management is a HACCP expectation in that any change should trigger a new risk assessment. Equipment placement, new traffic patterns, and any operational changes can impact ingredient flow and the quality/safety of the confectionery item produced at the site.

SECTION # 5: FACTORY OPERATIONS Objectives: The need to keep all materials identified throughout the process is critical for effective traceability. This is a product security requirement in addition to being a GMP requirement. Rework is often a component of confectionery recipes, and along with any other in - process materials removed from the line for subsequent re-introduction, must be identified and controlled. GMPs include the prerequisite programs for control of hazards such as wood,plastic, glass, and metal foreign materials. The HACCP approach demands a risk assessment be completed for all areas of the process, and a specific means be identified for hazard control in the process flow, by PRP or CCP. Product specifications must be documented to define all critical quality attributes and requirements for food safety. Various in-line protection devices such as filters , screens, and magnets will usually be required for confectionery processes, and their placement will determine the effectiveness of their performance. Metal detection systems are also typically required for all confectionery processes, and are often integrated into line operations as a CCP. It is very important that all operators are properly trained in their job responsibilities, and that they have documented work instructions to follow when doing their jobs. This is especially true for critical cleaning and sanitation procedures. Each confectionery operation should follow a master sanitation schedule, and have documented procedures for effective cleaning and sanitation of environments and equipment.

Many confectionery operations will use automated cleaning systems such as CIP units ( clean in place ), and mold washing equipment. It is common in confectionery plants, especially in chocolate making facilities, to employ dry cleaning practices; this too must be well documented and controlled to comply to GMPs. Some level of verification and testing may be required to monitor cleaning and sanitation for microbiological control and for control of food allergens. In addition, operations control will often need monitoring for compliance to legal and regulatory requirements such as weight control of packages or package seals for tamper evidence, and adherence to nutritional labeling and product claims. This also applies to Federal, State, and local rules that are given as GMPs, and trade or dietary requirements such as organic and Kosher. Definitions:

HACCP a system which identifies, evaluates, and controls hazards which are significant for food safety; a CCP is an identified Critical Control Point in the process.

Pre-requisite programs (PRPs) are quality and food safety programs such as GMP used by food processors to support the preventive approach defined by HACCP

Standard Operating Procedures (SOP) is the companys own defined and documented best practice for accomplishing a process step in manufacturing their products

Rework any materials, including packaged products, that have been produced using ingredients, taken off line, which can subsequently be re-introduced into the product recipe in a specified amount

Specifics for Confectionery Products: In general there are very few CCPs in a confectionery operation; the KEY is to manage the Prerequisite Programs that support the HACCP approach. For chocolate operations, a CCP is cocoa bean roasting, for gum and sugar products it would possibly be the metal detection or packaging bar code reader in a wrapping operation. 5.1: HACCP: The basis for the manufacturing confectioners food safety program is Hazard Analysis Critical Control Point, HACCP. GMPs and basic food hygiene are prerequisite programs that form the foundation for HACCP. Compliance to the requirements of the GMP and food hygiene PRPs is necessary for implementation and effective operation of HACCP.

5.2: Material receiving and storage: Areas of the site, including off site storage facilities, must be maintained to protect the integrity of all raw materials and

packaging. Proper maintenance and cleaning of dock areas and warehouse facilities are a critical part of the GMP program.

5.2.1 Material receiving

5.2.1.1 Special attention should be given to bulk unloading practices. Ancillary equipment such as unloading hoses, couplings, filters/screens/magnets, tanker lids and screens can be sources of contaminants, and need to be cleaned and often dedicated to the receiving area of the plant.

5.2.1.2 Sampling of materials for acceptance testing or reference, and

trailer inspection for incoming ingredients/packaging should be conducted to avoid contamination of the materials. Certificates of Analysis ( COAs ) should be reviewed as required and properly filed.

5.2.2 Material storage

5.2.2.1 Material shelf life needs to be maintained; a FIFO system is typically used. Materials left over from product runs must be properly labeled and stored for future use. Temperature and humidity controls in storage areas for both packaging and raw material storage are critical elements to monitor and maintain.

5.2.2.2 It is normal to expect an 18 inch perimeter to be kept for

cleanliness and access for pest control management.

5.2.2.3 Allergen storage requirements may be necessary for sensitive ingredients. Although the distance will be different from plant to plant, types of rules for separation may be defined as a pallet width apart, 10 feet, across an aisle, etc. In some cases, a separate room could be necessary. Color coding in storage racks is often used to make it easy for the operator to identify proper areas for allergenic ingredient storage, The business rules should be part of the manufacturing confectioners Allergen Control Plan.

5.2.2.4 Similar to allergenic ingredients, microbiologically sensitive raw

materials may require isolated environmental conditions For example, raw cocoa beans, raw peanuts and raw flour must be held in separate areas/silos to prevent pathogenic organisms from cross contaminating processed ingredients and finished products/packaging.

5.3: Process controls are necessary to prevent food safety and quality issues. Standard Operating Procedures and equipment calibration are means to achieve compliance to

this area of GMPs. For the manufacturing confectioner there will be a variety of monitoring systems and process checks required to ensure safe and high quality finished product.

5.3.1 Calibration is an absolute requirement for equipment involved in CCPs.

Typically there is a predetermined procedure for equipment validation, and a documented frequency for calibration and verification. These could apply to coca bean roasting, peanut roasting, a baking operation, metal detection, or an allergen cleaning.

5.3.2 Scales and checkweighers need to be maintained for products and tare

weights. A certification is typically required at least annually for finished product weight scales. Weight control process checks are expected as part of GMPs, to confirm legal requirements are met. For some confectionery operations, piece count may also be a critical parameter; especially is it is declared on the package.

5.3.3 Metal detection and reject mechanisms with secured reject bins are

common GMP expectations for all manufacturing confectioners. There should be documented methods for challenging the systems to assure on-going effectiveness. These are most often test beads approximately 2mm in diameter made from ferrous and non-ferrous/stainless steel metals.

5.3.4 Filters, strainers, and screens which are sized appropriately for a process

area are required for GMPs. These are known in the confectionery industry as consumer protection devices. Each process will be different, but they must be checked with regularity to assure the integrity of materials being processed into finished products. Their purpose is to minimize the possibility of foreign materials and unacceptable food particulates. They also serve to protect process equipment. Procedures need to be in place to hold product to the previous good check when an issue is observed.

5.3.5 Magnets of varying types (finger, rare earth magnet) are used in many confectionery operations. For example, they are very common in chocolate making processes. These consumer protection devices apply only to metals with magnetic properties. As discussed for filters and screens, they too must be checked with regularity to monitor their effectiveness, and a procedure must be in place to instruct operators what to if an equipment failure is indicated.

5.3.6 Standard Operating Procedures

5.3.6.1 As a component of a strong GMP program it is recommended that

the manufacturing confectioner have documented Work

Instructions for operators who perform critical process steps. Those operators must be properly trained to assure they have adequate equipment knowledge to make decisions important to maintaining product quality and safety

5.3.6.2 Quality Assurance and laboratory testing methods need to be

documented and controlled as part of the GMP program. This also applies to sampling procedures and inspection/auditing procedures in the manufacturing plant, in off site warehousing and storage areas, and in transportation vehicles for incoming materials and outbound shipments.

5.3.6.3 Sanitation procedures ((SSOPs) and operator work instructions are

expected as a part of GMPs. This includes operator training in specific needs for equipment cleaning, and process knowledge for cleaning the facility environment. A master sanitation schedule should be prepared to show when cleaning and sanitation is applied to all site equipment and process/non-process areas.

5.4 Packaging and code dating is a critical areas for GMP compliance. Some are legal requirements while some are expectations by customers and consumers of confectionery items.

5.4.1 There should be a regular label review conducted for all packaging

components to confirm the correctness of all ingredient information and any food allergen statements. In addition, product claims, promotions, and package weights/counts must be correctly applied to packages.

5.4.2 Packaging and code date checks

5.4.2.1 Seal integrity should be regularly checked for its thoroughness. It

is recommended that confectionery manufacturers achieve a tamper evident package for their primary wrappers.

5.4.2.2 Code date information should be applied such that it is clear and

legible. Also, code dates should accurately reflect the time of manufacturing to permit traceability for product recall, and to comply with Bioterrorism ( Product Defense ) legislation.

5.5 Sampling, testing, and inspection of ingredients and products is expected as a

part of compliance to GMPs. This shows the manufacturing confectioner is concerned with producing items that conform to the quality specifications given in the product design, and that all relevant product safety risks are being managed.

5.5.1 Receiving of ingredients and packaging materials is managed by a prerequisite Supplier Assurance program coupled with COAs required from the supplier, along with inbound verification checks.

5.5.2 In-process testing confirms batch control at critical process stages, and

may be a HACCP requirement for monitoring CCPs, if they have been identified. For example, key quality attributes may indicate the need to test for sensory conformance (color and flavor), moisture, particle size, etc. There may be a need to conduct microbiological tests or allergen swabs to verify process control.

5.5.3 Environmental testing should be a component of the GMP program.

Certain areas of the plant, and some equipment contact surfaces, may require monitoring for microbiological and/or allergen control. Cleanliness in some environments may require air samples to check for dust, mold, etc.

5.5.4 Finished goods sampling and testing should be conducted to confirm the

product is acceptable for shipment to customer. The level of sampling and testing will depend on the risk evaluations conducted, and will vary according to the type of confection and the complexity of the operation.

5.6 Rework and scrap management needs to be included in the GMP program.

5.6.1 Finished product rework is used in many confectionery operations. If it is part of the product recipe, the materials must be properly contained and stored. All containers must be clearly labeled with dates for traceability and stock rotation, usually a FIFO rule for using the oldest product first. Some confectioners use color coding to avoid misuse of materials. A typical policy for confectioners that use rework, is to use like into like; in order to be true to product recipes, and prevent allergen cross contact contaminations.

5.6.2 Left over packaging material must be controlled. Misbranding and

mislabeling can occur if the wrong product gets packed into the wrong package. This situation could result in an allergen labeling issue. Also, obsolete packs may have outdated promotions and claims that no longer represent the packed items. As with ingredients held over from a run, packaging must be properly labeled and stored.

5.6.3 Scrap and waste materials must be properly handled throughout the plant.

Potentially contaminated materials such as cafeteria or locker room waste should travel a specific route to a collection point to prevent product contact. All waste must be properly labeled and contained; it is

recommended to use a specific color for containers that handle only scrap/waste materials.

5.7 Site regulatory inspection management should be a part of every GMP program. An inspector should be accompanied by a trained facility associate at all times. There should be a documented procedure that instructs the site representative to provide notification of the pending inspection, how to manage records access by the inspection agent, and how to follow-up on any reported findings.

5.7.1 Kosher claims are common in the confectionery industry and present a

regulatory constraint for the manufacturer. If claimed, it should be a part of the GMP program with attention focused on cross contamination concerns with prohibited ingredients/materials

5.7.2 Military requirements are a concern for confectioners producing items

for military consumption. GMPs should reflect that the military will conduct a comprehensive audit of plant and processes affiliated with items purchased, and their customer requirements may vary depending on the product risk and where it will be used.

5.7.3 Dept of Agriculture may conduct regulatory audits on behalf of Food &

Drug Administration (FDA) or they may conduct routine GMP/Sanitation inspections based on the type of confectionery items being produced at the site.

5.7.4 FDA typically has jurisdiction over all confectionery processors. and will

routinely conduct GMP and sanitation audits of all processing facilities. They may want to inspect a plant as part of an investigation, having a specific cause or focus to be addressed during the audit. Examples include plant surveys for emerging food safety issues such as food allergens, specific consumer complaints involving the companys product, or in response to an industry wide problem such as a microbiological pathogen in a raw material (e.g., Salmonella in peanuts).

5.7.5 In addition to the above, State/local/Dept of Health site inspections may be

conducted, and food service inspections for plants that have their own cafeterias. All of these should be included in the companys GMP program. The confectioner should be prepared for inspections that may come in response to a site specific incident, to local requirements, or at the request of FDA

5.8 Internal auditing and corrective actions should be integrated into the

companys GMP program. This should be a core area for the quality and food safety program management for all confectionery plant operations. It will

identify if policies and procedures are firmly in place, or if they are tending to drift away from their intended functions. It will give the manufacturing confectioner a base for measuring their own performance, and give them a platform for achieving continuous improvement.

SECTION # 6: FINISHED GOODS STORAGE AND TRANSPORTATION Objectives: Once the products are in their final packages, there is still a need to comply to GMPs to ensure delivery of safe and acceptable quality to consumers and customers. Storage areas must be controlled for effective management of shelf life. Most confectionery processors will conduct finished product audits to verify conformance to specifications. Most often a finished goods library will be maintained for at least the shelf life of the products; this is valuable for any issues that arise in the field and may be reported as consumer complaints. The subsequent shipment and off site storage of products are still the responsibility of the manufacturer, until the product is sold to a customer. Specific requirements for shipping and handling should be documented to assure that special needs for the confectionery items are met. For example, chocolate products require strict temperature control during shipment and storage. If there are product issues that need to be resolved, the company must be able to contain the product using an effective hold management process, and, if necessary, apply an effective recall process to quickly retrieve all of the affected items. Definitions:

Recall; the act of removing finished products from the marketplace; typically with public announcement and notification to regulatory authorities Traceability; the companys ability to track the ingredients and packaging used to make a finished item, any interim products produced during the manufacturing process, and all of the end products made and distributed to specific retail customers Quality Hold (physical hold vs electronic hold); the act of designating and isolating a quantity of product or materials that needs to be further evaluated for conformance to quality or food safety specifications Non-conforming product; products found to be out of specification and unacceptable for further processing, or for sale to a customer

6.1: Finished goods storage GMPs require temperature and humidity control, knowledge of product location, and FIFO stock rotation. These combine to assure the confectioner will deliver good quality product to customer and consumers. In many cases, the manufacturer will use off-site storage managed by a warehouse vendor for their products, and should be responsible for audits and accurate inventory control. For confectioners

that produce food service items and bulk goods for further processing, the same GMP requirements should apply for maintaining product quality and traceability. 6.2: Product shipment and transportation activities require temperature and humidity control to be maintained in the supply chain. This may be a challenge when customer pick up practices and third party carriers are outside the confectioners control. GMPs in this area also include assuring the cleanliness of trailers and railcars, wash certificates and their verification, and special handling requirements for exported items. 6.3: Containment of non-conforming products is a required GMP. An effective hold management process must be in place to be sure that all product put on hold remains on hold, and products that are released actually are shipped. Product that is determined to be unacceptable and is destined for destruction must be physically destroyed with certification. In cases involving a food safety incident, it should be a GMP requirement for confectioners to provide an on-site company representative to witness the destruction. 6.4: Recall procedures and product traceability are requirements for all food processors. The confectioner must ensure that product can be identified and tracked from the receipt of materials at their site, through ingredient processing and product packing, to the shipment and acceptance of that product by the customer. It is recommended that the confectioner be capable of specific lot code tracking that can identify the time of production as nearly as possible. As mentioned before in this document, traceability is a regulatory requirement for product security (Bioterrorism Legislation @ 2002). The companys ability to manage a product recall should periodically be tested using mock recalls and incident simulation exercises; it is recommended that it be done twice annually. 6.5: Import and export controls are important GMP considerations for companies that actively participate in this area. The confectioner must understand what items are received and shipped, where and for how long they are being held, and what will be the distribution plans for the items when they are finally converted for retail sale. For example, some confectioners will ship bulk, wrapped items to China for incorporation into a finished packages that will, in turn, be shipped back to the US. The original confectionery producer still has responsibility for the products, and needs to be able to trace the items throughout the supply chain network. SECTION 7: CUSTOMER AND CONSUMER Objectives: GMPs need to be comprehensive to the point of consumption. Brand protection should always be a concern of the manufacturing confectioner. Product safety and integrity should be maintained throughout the pipeline. Customer/retailer feedback will help ensure that the trade understands the full extent of product requirements, and will highlight any issues in managing the items to promote consumer delight. Consumer complaints, inquiries, and compliments will provide a level of sensitivity often unavailable by sampling and product audits. A strong system to listen

to information from customers and consumers can help promote continuous improvement to product quality and can assure a quick reaction to any product safety issues. Definitions:

Crisis management; the companys ability to identify and work through a crisis situation that may or may not involve products

Incident management; the companys ability to identify, evaluate, and manage a product related quality or food safety issue.

7.1: The product information given in the package ingredient declaration is critical for customers and consumers. The companys GMP program must assure the accuracy of the ingredient declaration. The confectioner should listen to inquiries and complaints from customers and consumers, especially those pertaining to illness/injury, food allergens and sensitivities such as gluten, colors, sulfites, tartrazine, GMOs, and those regarding potential contaminants such as lead, melamine, formaldehyde, etc., and physical contaminants. 7.2: GMPs must also include the accuracy of product labeling for nutritional information, health claims , Kosher, and package graphics showing color, shape, and basic product design. It is also important to use GMPs to protect against any misinformation from promotional activity such as contests, games, etc. that may not be deliverable to the customer/consumer as intended by the business. 7.3: Customer and consumer contact management is a critical area for the GMP program. The confectioners business practices should have a means to reach out to customers and consumers; many use a toll free call line. Internally, the business should maintain an emergency list of numbers to quickly react to product safety risks reported by customers or consumers. This list will typically include all levels of management for quick notification and decision making.It is important to understand consumer trends available from contact information, which can proactively anticipate consumer/customer issues. A confectionery business can use customer/consumer contact investigations and effective follow-up as a performance metric.