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

3.1.1.2

An appropriate handwashing method requires warm water,

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

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

4.2.2

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.

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

4.2.3

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.

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 reintroduction, 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 reintroduced 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 ongoing 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

5.4

5.5

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.

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.

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.

5.6

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.

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

5.8

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

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.