Food Safety GMP Manual
Company recognizes its responsibility as a producer of quality food
products. To this end, XYZ Company has developed and
documented a food
safety management system to better satisfy the needs of its customers
improve management of the business. The food
system complies with the CFR 21 Part 117: Current
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Control for Human Food. The
food safety management system
also complies with the international standard ISO 22000:2005, Food
management systems – Requirements for any organization in the food
chain, and ISO/TS
22002-1:2009, Prerequisite programs on food safety –
Part 1: food manufacturing.
manual has been prepared to define the management system,
responsibilities of the personnel affected by the system, and to
general procedures for all activities comprising the management
In addition, this manual is utilized for the purpose of informing our
of the management system and what specific controls are implemented to
quality and safe food.
manual will be revised as necessary to reflect the management system
in use. It is issued on a controlled copy basis to all
affected by the safety system and on an uncontrolled copy basis to
and suppliers, although it can be issued to customers on a controlled
basis upon customer request.
CONTROL OF DOCUMENTS
Company identifies and controls documents required by the food safety
management system according to the Control of Documents
ensures that documents:
are reviewed and approved for adequacy
prior to issue;
are updated, reviewed, and approved for
re-issue as necessary;
are identified with their current
are available at point of use;
are legible, readily identifiable, and
of external origin are identified and
their distribution is managed;
that are obsolete are prevented from
unintended use and are suitably identified if they are retained for any
defined as records are managed per the Control of Records
XYZ Company’s management provides evidence
of its commitment to the
development, implementation, and continual improvement of the food
safety management system.
XYZ Company shall provide
adequate resources for the establishment, implementation, maintenance
and updating of the food safety management system.
management is committed to provide adequate resources to implement and
improve the processes of the food safety management system and promote customer satisfaction. The food
safety team and the other personnel carrying out activities having an
impact on food safety are competent and have appropriate education,
training, skills, and experience.
assistance of external experts is required for the development,
implementation, operation, or assessment of the food safety management
system, records of agreement or contracts defining the responsibility
and authority of external experts are available.
For details, refer to the Control
of Records Procedure.
resources for implementation and improvement of the food safety
management system and for addressing customer satisfaction may
include any of the following: information,
employees, external experts, infrastructure, work environment, and
financial funds. The
principal means for determining and communicating resource requirements
are management reviews of the food safety management system. For details, refer to the Management
The food safety
manager and all management personnel affected by the food safety
management system are responsible for determining resource requirements
for the implementation and improvement of the system.
Resources for designated activities are
integrated with the process of defining and initiating the activity. They may take the form of
personnel assignments, allocation of space or equipment, training,
procurement decisions, budgets, etc.
personnel that are responsible for identifying sanitation failures or
food contamination have a background of education or experience, or a
combination thereof, to provide a level of competency necessary for
production of clean and safe food.
Food handlers and supervisors receive
appropriate training in proper food handling techniques and
food-protection principles and are informed of the danger of poor
personal hygiene and unsanitary practices.
PRODUCTION AND PROCESS CONTROLS
XYZ Company has established and
maintains documented risk-based plans and procedures to ensure that
processes and sub-processes are conducted under controlled conditions
and yield safe products. Planning
of the production processes is consistent with the other requirements
of XYZ Company’s food safety management system.
XYZ Company has implemented, operates and ensures
the effectiveness of the planned preventive activities and any changes
to those activities. This includes PRP(s) as well as
operational PRP(s), the HACCP plan, and/or the Food Safety Plan.
Preliminary Steps to Enable Hazard
relevant information that is needed to conduct a hazard analysis is
collected, maintained, updated, and documented. Records are
maintained per the Control of Records Procedure.
Food Safety Team
XYZ Company has appointed a food
food safety team is comprised of
multi-disciplinary members that posses the required knowledge and
developing and implementing the food safety management
includes, but is not limited to, XYZ Company’s products, processes,
and food safety hazards within the scope of the food safety management
Safety Plan is prepared, or its preparation is overseen, by a
controls qualified individual”. The qualified individual (QI)
training that is at least equivalent to a program recognized by the FDA
sufficient education and experience relevant to food safety.
that demonstrate that the food safety team has the required knowledge,
skills, and experience are maintained per the Control of
Prevention of Cross Contamination
The material contact containers and material
handling equipment are cleaned prior to use in production. Utensils
and equipment that have come in contact with the floor, waste or other unsanitary objects are
cleaned prior to making contact with product.
Employees, equipment, utensils and
protective garments that are utilized for raw material are not utilized
for finished products. Employees
working in production and storage areas are not permitted to work in
packing and labeling areas. In
the event it will be necessary to transfer the employee into these
areas, they will first clean and sanitize their hands and change their
outer garments. Hand-washing stations and hand dips at the start
and end of each process line are maintained.
Employees are trained in how to properly wash and sanitize. The training is documented
and records are stored on file.
containers are not left open to prevent contamination with in-process
and finished product.
The production of one product is kept separate from the
production of other products. Before
starting production of a different product,
the floor and all applicable workstations and equipment
are properly cleaned and sanitized.
utensils, buckets and containers are maintained for different products in
usage. Should any
form of waste or floor splash contaminate the process line, the
production supervisor/manager will immediately stop the process line. The section affected will
be cleaned, sanitized and inspected before production is restarted. Food-manufacturing areas and equipment
used for manufacturing food for human consumption are not used to
manufacture food-grade animal feed or inedible products, unless there
is no reasonable possibility for the contamination of the food for
to sending completed product to packing and
labeling, all containers are thoroughly cleaned externally to prevent
Handling, Storage, Packaging, Preservation, and Transportation
XYZ Company ensures that incoming
material (i.e., raw material, ingredients, livestock, hatching eggs,
chicks, packaging material, returned finished product, food and
non-food chemicals) are transported, received, stored and handled in a
manner to prevent chemical, physical or microbiological contamination
of food. Incoming
materials are received in an area separate from processing area(s).
Raw materials are washed or cleaned as
necessary to remove soil or other contamination.
Effective measures are taken by XYZ
Company to prevent contamination of raw materials, ingredients and
packaging materials. The XYZ Company does not accept
incoming materials if they are known to be contaminated with the
- toxic substances
- undesirable microorganisms
- veterinary drugs
- decomposed or extraneous
Incoming materials that require
refrigeration are stored at regulated and/or acceptable temperatures
and are appropriately monitored. If
thawing is required prior to use, it is done in a manner that prevents
the materials from becoming adulterated.
Incoming materials that are sensitive
to humidity are stored under appropriate conditions to prevent
and dry raw materials and other ingredients that are received and
stored in bulk form are stored in a manner that protects against
(c) Copyright 1997, 2008
Quality Systems Innovations, Inc.