BICOL UNIVERSITY COLLEGE OF ENGINEERING

DEPARTMENT OF CHEMICAL ENGINEERING

Safety in Process Industries

SY 2019-2020, 2nd semester

GMP and HACCP

MEMBERS
BASAYSAY, Ehra Joy LOVERANES, Marina
BORDEOS, Jael MATEDIOS, Kimberly
BORROMEO, Kenneth Nestor MOLO, Francine Dawn
ISRAEL, Nelvie Jean PEYRA, Phil Joshua

I. Current Good Manufacturing Practices (cGMP)

Definition
(1) The aspect of quality assurance (QA) that ensures that products - food, drinks, medicines, cosmetics
and medical devices primarily - are consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the product specification.
(2) It defines quality measures for both production and quality control and defines general measures to
ensure that processes necessary for production and testing are clearly defined, validated, reviewed
and documented, and that the personnel, premises and materials are suitable for production.
(3) It has also legal components, covering responsibilities for distribution, contact manufacturing and
testing, and responses to product defects and complaints.
(4) These practices are adequately implemented to prevent instances of contaminations, mix-ups,
failures and error and assures that products meet their quality standard.
Administrative Order No. 153 s. 2004

- Also known as “Revised Guidelines on Current Good Manufacturing Practice in Manufacturing,

Packing, Repacking, or Holding Food”
- A revision of the Administrative Order No. 208 s. 1974 “Human Foods; Current Good
Manufacturing Practice (Sanitation) in Manufacture, Processing, Packing of Holding”
- Aims to align cGMP for human food with international standards (e.g. USDA and/or EU cGMP)
- As stipulated in Section 4 of the AO, the following are the general guidelines for GMP:

A. GMP ORGANIZATION

-there shall be an adequate number of personnel, as determined by the company, at all levels having
knowledge, skills and capabilities relevant to their assigned functions, in good mental and physical
health to be able to execute their duties.
 - ALL employees who are directly engaged in the manufacturing activities shall be trained (in
continuing basis) in the particular operations they perform in accordance to the principles of GMP.

B. PREMISES

1. Grounds shall be constructed and maintained to protect against weather, flood, ground seepage
and the access and harboring of vermin, rodents, birds, insects or other animals.
2. Grounds about a food plant under the control of the operator shall be kept in a condition that will
protect against the contamination of food:
2.1. Good Housekeeping
Properly storing equipment, removing litter and waste, cutting weeds or grass within the
vicinity which may harbor pest
2.2. Waste Treatment and Disposal
Must be operated in conformance with DENR regulation, designed appropriately and does
not constitute a source of contamination of areas where food/raw material/product is
exposed
3. Plant, buildings, and structures shall be of suitable size, design, and construction to facilitate
maintenance and sanitary operations for food manufacturing purposes. The individual working
areas shall be adequate so that any risk of confusion and cross-contamination that will affect the
safety of food manufactured will be avoided.
4. Master Plan Diagram
This predicts where routes could lead to cross contamination, where new barriers may be necessary
and generally to reduce carriage od dirt and potential contaminants around the factory. The diagram
must show the following:
 Building outline
 Access for personnel and traffic ways
 Rivers, canals and other water catchment areas
 Approximate potential origins of problems (e.g. housing, industries etc.)
 Waste Collection areas
 Prevailing wind direction
 Waste utilities
 Definition of main areas in terms of hygiene zones and functions
 Planned cleaning practices (by area)
5. There shall be defined areas for the following operations:
 Change rooms for personnel
 Receiving of starting materials
 Incoming goods quarantine
 Sampling room for sampling of deliveries of starting materials
 Storage for approved materials (chemical and packaging)
 Storage of reject materials
 Quality Control facilities
 Preparation of materials
 Processing operations
 Equipment washing
 Storage of cleaned, idle or non-functional equipment
 Major repair and maintenance activities
 Storage of cleansing tools and supplies
 Staging/storage of bulk products
  Packaging/labelling operations
 Quarantine storage for finished products
 Storage/warehouse for approved finished products
 Canteen
6. There must be adequate natural or artificial lighting throughout the establishment.
7. Adequate ventilation shall be provided to prevent excessive build up of heat, dust odors and
vapors (including steam and noxious fumes) in areas where they may contaminate food/product.
8. Adequate screening/protection against pests.

C. EQUIPMENT

1. Equipment and utensils directly and indirectly utilized for food manufacture shall be designed
and constructed using non-reactive (non-toxic) materials that are easily cleanable and
maintained. Surfaces should be smoothly bonded and maintained to minimize accumulation of
food particles.
2. Equipment shall be suitable installed and located to eliminate cross contamination and facilitate
the cleaning of equipment and of adjacent spaces. All equipment shall be installed at least 1
meter apart.
3. Cleaned and sanitized portable equipment and utensils with product-contact surfaces shall be
stored in a manner that protect the said surface from splash, dust and other contamination.
4. Equipment should be calibrated, checked, labelled, sterilized regularly and is accompanied with
its Standard Operating Procedure (SOP).
5. Equipment should not have glass parts, unless otherwise, it should be shatter proof. Equipment
should also not be lacquered nor painted.
6. All equipment must allow for sampling and measuring of product quality.

D. SANITATION AND HYGIENE

1. Personnel
The plant management shall define its policy and document its procedures on sanitation and
personnel hygiene and take all reasonable measures and precautions to ensure the following:
1.1. Disease Control
Any personnel who, my medical examination is shown to have or appears to have an
illness, or any other possible source of microbial contamination shall be excluded from
any food handling/contact until the condition is corrected.
1.2. Hygienic Practices
All personnel working in direct contact with food, food contact surfaces, and food-
packaging materials shall conform to hygienic practices while on duty to the extent
necessary to protect against contamination of food.
 Wearing appropriate PPEs
 Maintaining adequate personal cleanliness
 Washing hands thoroughly
 Removing all unsecured jewelry and other subject which might fall into food,
equipment or containers
 Eating, drinking and smoking should not be allowed in production area
2. Education and Training
A training program shall be established and maintained to define appropriate training necessary
for food handlers and supervisors on proper food handling techniques and food-protection
 principles. This should be regularly instituted and validated to ensure compliance of personnel
to established procedures and work instructions.
3. Supervision
Authority and responsibility for assuring compliance to established procedures and work
instruction and identifying sanitation failures or food contamination by all personnel shall be
clearly assigned to the Shift Hygiene and Sanitation Officer or any other title.
4. Sanitary facilities
Each plant shall be equipped with adequate sanitary facilities such as:
 Water Supply
*Potable Water – used as product ingredient, for cooling and heating
*Non-potable Water – for fire control, refrigeration and oter similar purposes which are
not used in food manufacture
 Effluent and Waste Disposal
 Changing Facilities
 Toilets
 Hand-washing Facilities in Processing Areas
 Disinfection Facilities
 Facilities for Storage of Waste and Inedible Material
 Eating Facilities
5. Maintenance and Sanitation
5.1. General Maintenance
 Establishments and equipment should be kept in an appropriate state of repair
and condition to facilitate all sanitation procedures and prevent contamination
e.g. from metal shards, flaking plasters, debris and chemicals
 Cleaning should remove food residues and dirt which may be a source of
contamination. The necessary cleaning methods and materials will depend on
the nature of the business. Disinfections may be necessary after cleaning.
 Buildings, fixtures and other physical facilities of the plant shall be kept in
good repair and shall be regularly cleaned and maintained in a sanitary
condition.
 Detergents, sanitizers and other supplies employed in cleaning and sanitizing
procedures should be safe and effective for their intended uses. Toxic materials
which are used for sanitation must be properly stored and used in amounts that
ensures their safe use.
 In cases of risk of food contact, food grade materials for maintenance must be
used
 Maintenance personnel must be trained on specific maintenance procedures on
quality and hygiene before allowing them to work during Plant Maintenance.
5.2. Cleaning Procedures and Methods
Cleaning can be carried out by the separate or the combined use of physical methods
such as heat, scrubbing, turbulent flow, vacuum cleaning or other methods that avoid
the use of water, and chemical methods using detergents, alkalis or acids.
5.3. Cleaning Programs
Cleaning and disinfection programs should ensure that all parts of the establishment
are appropriately clean and should include the cleaning of cleaning equipment. These
programs should be continually and effectively monitored for their suitability and
effectiveness where necessary, documented.

Written cleaning programs should specify the following:

 Areas, items of equipment or utensils to be cleaned
 Responsibility for particular tasks
 Method and frequency of cleaning
  Monitoring arrangements
5.4. Animal, Vermin and Pest Control
 Animals or birds shall not be allowed in any area of a food plant
 Measures shall be taken to exclude pests from the processing areas and to
protect against contamination of foods on the premises by animals, birds and
vermin
 The availability of food and water encourages pest harborage and infestation.
Potential food sources and refuse should be stored in pest proof containers
and/or stacked above the ground away from walls.
 Keep both inside and outside food premises clean.
 Establishments and surrounding areas should be regularly examined for
evidence of infestation.
 Pest infestations should be dealt with immediately and without adversely
affecting food safety and suitability. Treatment with chemical, physical or
biological agents should be carried out without posing a threat to the safety
and suitability of food.

E. PRODUCTION AND PROCESS CONTROLS

1. Production Processes and Controls
All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing,
packaging, and storing of food should be conducted in accordance with adequate sanitation
principles.
To prevent problems, which could affect consumer safety or satisfaction, each line must be under
control. Hazard and root cause analyses must be used to specify control measures: Critical Control
Points (CCPs) for food safety and Control Points (CPs) for consistency.
1.1 Raw Materials and Other Ingredients
There shall be procedures and work instructions for the sanitary handling of raw materials and other
ingredients.
1.1.1 Raw materials and other ingredients shall be inspected and either segregated or otherwise
properly handled to ascertain that they are clean and suitable for processing into food.
1.1.2 Raw materials and other ingredients shall either not contain levels of microorganisms that
may produce food poisoning or other disease in humans, or they shall be pasteurized
or otherwise treated during manufacturing operations so that they no longer contain
levels that would cause the product to be adulterated within the meaning of the act.
1.1.3 Rework items shall be held in bulk, or in containers designed and constructed so as to
protect against contamination and shall be held in a manner that will prevent the food from
becoming contaminated within the meaning of the act. Material scheduled for
reprocessing shall be identified as such.
1.1.4 Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior
to use, it shall be done in a manner that prevents their becoming contaminated within
the meaning of the act.
1.2 Manufacturing Operations
Procedures and work instructions shall be established for the sanitary handling and maintenance of
equipment and utensils for manufacturing operations.
1.2.1 Equipment and utensils and finished food containers shall be maintained in a sanitary
condition through appropriate cleaning and sanitizing. Where appropriate, equipment shall
be taken apart for thorough cleaning.
1.2.2 Physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and
manufacturing operations such as freezing, dehydration, heat processing, acidification, and
refrigeration shall be monitored to ensure that mechanical breakdowns, time delays,
temperature fluctuations, and uncontrolled events do not contribute to the decomposition
or contamination of food.
1.2.3 Food that can support the rapid growth of undesirable microorganisms, particularly those
of public health significance, shall be handled in a specified manner that prevents the food
from becoming contaminated within the meaning of the act.
1.2.4 Work-in-process shall be handled in a manner that protects against contamination.
1.2.5 Finished food should not be handled together with raw materials, other ingredients, or
refuse in a receiving, loading, or shipping area if that handling could result in contaminated
food. Food transported by conveyor shall be protected against contamination.
1.2.6 Sieves, traps, magnets, electronic metal detectors, and other suitable means should be
used to protect against the inclusion of metal or other extraneous material in food.
1.2.7 Glass, foreign matter should likewise be prevented from contaminating food by exclusion
of the use of breakable glass as processing equipment, sampling containers, laboratory
glassware, etc. in production areas.
1.2.8 Food, raw materials, and other ingredients that are adulterated/contaminated within the
meaning of the act shall be disposed of in a manner that protects against the contamination
of other food.
1.2.9 Food such as but not limited to, dry mixes, nuts, intermediate moisture food and dehydrated
food, that relies on the control of a for preventing control of undesirable microorganisms
shall be processed and maintained at safe moisture level at all times.
1.2.10 Processes such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling
pH or controlling aw that are taken to destroy or prevent the growth of undesirable
microorganisms, particularly those of public health significance, shall be adequate under
the conditions of manufacture, handling, and distribution to prevent food from being
contaminated within the meaning of the act.
1.2.11 Physical protection of food from contaminants that may drip, drain, or be drawn into the
food during operations like washing, peeling, trimming, etc. shall be done properly to
protect food against contamination. Protection may be provided also by adequate
cleaning and sanitizing of all food-contact surfaces, and by using time and temperature
controls at and between each manufacturing step.
1.2.12 Heat blanching, when required in the preparation of food, should be effected by heating
the food to the required temperature, holding it at this temperature for the required time,
and then either rapidly cooling the food or passing it to subsequent manufacturing without
delay.
1.2.13 Batters, breading, sauces, gravies, dressings, and other similar preparations shall be
protected against contamination by any effective means.
1.2.14 Filling, assembling, packaging, repacking and other operations shall be performed in a
manner that protects food against contamination by any effective means.
1.2.15 Food such as, but not limited to, acid and acidified food, that relies principally on the
control of pH for preventing the growth of undesirable microorganisms shall be
monitored and maintained at a pH of 4.6 or below.
1.2.16 Ice used in contact with food shall be made from potable water and shall be manufactured,
stored and handled in accordance with good manufacturing practice.
 1.2.17 Steam used in contact with food must be of food grade quality. Make-up water shall be
potable and comply with current food legislation standards. Steam pipe insulation should
be sealed, in such a manner that it does not become a hiding place for insects.
1.2.18 Food-manufacturing areas and equipment used for manufacturing human food should not
be used to manufacture nonhuman food grade animal feed or inedible products, unless there
is no reasonable possibility for the contamination of the human food.
1.2.19 All food manufacturing establishments using one or several critical allergens as ingredients
shall take all reasonable precautions to avoid cross contact of products that do not normally
contain these allergens and that do not normally carry a specific mention in the ingredient
statement.

F. QUALITY CONTROL

1. Quality Management
1.1 A quality control system should be established to ensure that products contain the
correct materials of specified quality and quantity and are manufactured under proper
conditions following standard procedures to ensure the quality and safely of the
product.
1.2 The quality control involves sampling, inspecting and testing of starting materials, in
process, intermediate, bulk and finished products. It also includes where applicable,
review of batch documentation, sample retention program, stability studies, product
complaints, product recalls, and maintaining correct specifications of materials and
products.
2. Testing of Reprocessed Products
2.1 The methods of reprocessing should be evaluated to ensure that they do not affect the
quality of the product.
2.2 Additional testing of any finished product, which has been reprocessed, should be
performed.
3. Testing of Returned Goods
3.1 Returned products should be identified and stored separately either in allocated area or
by moveable barrier such as rope or tape.
3.2 All returned products should be tested if necessary, in addition to physical evaluation
before being released for distribution.
3.3 Any returned products that do not comply with the original specification should be
rejected.
3.4 Rejected products should be disposed according to appropriate procedures.
3.5 Records of returned products must be maintained.
4. Laboratory Facilities and Controls
4.1 The laboratory shall be well designed to suit the relevant operations.
4.2 It shall be separated physically from the production areas.
4.3 Its concomitant facilities – laboratory equipment and instruments shall be suitable to
the testing procedures undertaken.

G. DOCUMENTATION

1. All documents related to the manufacture and operations from raw materials, packaging
materials, master production and control, batch production, laboratory control and batch
 production record review should be prepared reviewed, approved and distributed according
to written procedures.
2. The issuance, revision, superseding and withdrawal of all documents, should be controlled
by maintaining revision histories.
3. A procedure should be established for retaining all appropriate documents (e.g.
development history reports, scale-up reports, technical transfer reports, process validation
reports, training records, production records, control records, and distribution records). The
retention period for these documents should be specified.
4. Records of major equipment use, cleaning, sanitation, and/or sterilization and maintenance
shall show the date, time (if appropriate), product, and batch number of each batch
processed in the equipment and the person who performed the cleaning and maintenance.
5. Specifications shall be established and documented for raw materials, labelling and
packaging materials. Acceptance criteria should be established and documented for in-
process controls.

H. QUALITY AUDITS
A quality audit consists of an examination and assessment of all or part of a quality system with
the specific purpose of improving it. A quality audit may be conducted by outside or independent
specialists or an internal audit team designated by the management for this purpose. Such audits
may also be extended to suppliers and contractors, if necessary. A report should be made at the
completion of each quality audit.
I. WAREHOUSING AND DISTRIBUTION
There shall be appropriate procedures for sanitary handling of food on storage and distribution.
Storage and transportation of finished food shall be under conditions that will protect food against
physical, chemical, and microbial contamination as well as against deterioration of the food and
the container.
Warehouses should be kept free from rodents, insects, birds and other pests. All product spills
should be cleaned up immediately, as this is an important preventive measures against pests.
1. No pesticides, disinfectants, toxic chemicals or other contaminating materials must be
stored in close proximity to finished products or incoming products.
2. In plants, storage must be organized to ensure that potentially contaminated incoming
materials are not stored next to finished products.
3. Defective stock, market returns or complaint goods must be stored in a separate area
preferably locked.
4. Storage facilities must be secure enough to prevent theft, tampering, etc.
5. First in-first out system must operate and a stock control system must be in place.
6. All storage premises must be kept clean and tidy-not only inside but also in the surrounding
areas.
J. PRODUCT RECALL
1. All quality-related complaints, whether received orally or in writing, shall be recorded and
investigated according to a written procedure. Documented records of complaint should
be retained to evaluate trends, product-related frequencies and severity with a view to
taking additional and if appropriate, immediate corrective action.
2. There shall be a written procedure that defines the circumstances under which a recall
should be considered. The recall procedure should designate who should be involved in
 evaluating the information, how a recall should be initiated, who should be informed about
the recall, and how the recalled material should be treated.
3. In the event of a serious or potentially life-threatening situation, all concerned local and
national authorities shall be informed and their advice sought. If it is necessary to get in
touch with concerned international authorities, communication should come from the
national authority and not from the local companies.
4. It is important to have a record of the traceability of raw materials, packaging materials,
processing data and laboratory results which could be relevant to analyze the effectiveness
of the implementation of procedure for product recall.
K. RETENTION OF SAMPLES
Retention samples of a batch product provide a useful tool for the investigation of a product
complaint.
1. An appropriate and adequate number of samples of the finished batch product shall be
withdrawn from the production/packaging line to serve as reserve or retention samples.
The number shall be such that it will be adequate for a complete testing, if and when
necessary to do so.
2. Retention samples shall be stored in an area compatible with storage condition prevailing
in the market.
L. SUB-CONTRACTING OF MANUFACTURE
The conditions of contract manufacturing should be defined, agreed, and controlled so as to avoid
misunderstandings, which could result in a product or work of unacceptable quality. All aspects of
contracted work should be specified to obtain a quality product conforming to the agreed standards.
There should be a written contract between the principal and the contract manufacturer to clearly
establish the duties and responsibilities.

II. FOOD SAFETY STANDARDS (RA No. 10611)

Republic Act No. 10611 otherwise known as The Food Safety Act of 2013 – is an act to strengthen
the Food Safety Regulatory System in the Country to protect Consumer Health and facilitate market
access of local foods and food products, and for other purposes.
Article Title
I Title, Declaration of Policy and Objectives
II Definition of Terms
III Basic Principles of Food Safety
IV General Principles
V Responsibilities on Food Safety
VI Food Safety Regulation Coordinating Board (FSRCB)
VII Crisis Management
VIII Implementation of Food Safety Regulations
IX Training and Consumer Education
 X Food-borne Illness Monitoring, Surveillance and Research
XI Policy on Fees
XII Prohibitions, Penalties and Sanctions
XIII Final Provisions

What is Food Safety?

 The assurance that food will not cause harm to the consumer when it is prepared or eaten
according to its intended use.
Hazard – a property that may cause food to be unsafe (biological hazard, chemical hazard, and
physical hazard). Food safety hazards can be:

 Biological – When a food is contaminated by a living organism or a substance produced

by a living organism. (Bacteria, Viruses, Parasites, Molds, etc.)
 Physical – When a foreign object enters a food at any stage of the production process.
(Bones, Pits, Bugs, Glass, Metal, Hair, etc.)
 Chemical – When a food is contaminated by contact with a chemical substance. Chemical
contaminants can be “natural” or “artificial”. (Pesticides, Processing Chemicals, Drug
Residue, Allergens, etc.)
Objectives of the Safety Act of 2013
1. Public protection from food and water-borne illnesses and unsanitary, unwholesome,
misbranded or adulterated foods.
2. Enhance confidence in the food regulatory system.
3. Achieve economic growth and development by promoting fair trade practices and sound
regulatory foundation for domestic and international trade.
Food safety regulatory system refers to the combination of regulations, food safety standards,
inspection, testing, data collection, monitoring and other activities carried out by food safety
regulatory agencies and by the Local Government Units (LGUs) in the implementation of their
responsibilities for the control of food safety risks in the food supply chain.
Food safety standards refer to the formal documents containing the requirements that foods or
food processors have to comply with to safeguard human health.
What are the prohibited acts under the Food and Safety Act of 2013?
It shall be unlawful for any person to:
1. Produce, handle or manufacture for sale, offer for sale, distribute in commerce, or import
into the Philippines any food or food product which is not in conformity with an applicable
food quality or safety standard promulgated in accordance with this law.
2. Produce, handle or manufacture for sale, offer for sale, distribute in commerce, or import
into the Philippines any food or food product which has been declared as banned food
product by a rule promulgated in accordance with this law.
3. Refuse access to pertinent records or entry of inspection officers of the FSRA.
4. Fail to comply with an order relating to notifications to recall unsafe products.
 5. Adulterate, misbrand, mislabel, falsely advertise any food product which misleads the
consumers and carry out any other acts contrary to good manufacturing practices.
6. Operate a food business without the appropriate authorization.
7. Connive with food business operators or food inspectors, which will result in food safety
risks to the consumers.
8. Violate the implementing rules and regulations of this law.
What is FSRA?
FSRA stands for Food Safety Regulatory Agencies, which are the following national
government agencies:
1. Various agencies under the DA, which shall be principally responsible for food safety in
the primary production and post-harvest stages of food supply chain and foods locally
produced or imported in this category.
2. Various agencies under the DOH, which shall have the principal responsibility for the
safety of processed and prepackaged foods, foods locally produced or imported under this
category and the conduct of monitoring and epidemiological studies on food-borne
illnesses.
Principal Responsibilities of Government Agencies
DA – responsible for food safety in the primary production and post-harvest stages of food
supply chain and foods locally produced or imported in this category;
DOH – responsible for the safety of processed and prepackaged foods, foods locally produced or
imported under this category and the conduct of monitoring and epidemiological studies on food-
borne illnesses;
LGUs – responsible for food safety in food businesses such as, but not limited to, activities in
slaughterhouses, dressing plants, fish ports, wet markets, supermarkets, school canteens,
restaurants, catering establishments and water refilling stations. The LGU shall also be responsible
for street food sale, including ambulant vending;
– may be called upon by the DOH and the DA to assist in the implementation of food laws, other
relevant regulations and those that will hereafter be issued;
DILG – in collaboration with the DA, the DOH and other government agencies shall supervise
the enforcement of food safety and sanitary rules and regulations as well as the inspection and
compliance of business establishments and facilities within its territorial jurisdiction;
DA and the DOH – capacitate the LGUs and provide necessary technical assistance in the
implementation of their food safety functions under their jurisdiction. In compliance with tins
responsibility, they shall provide training to the DILG and the LGUs and shall periodically assess
the effectiveness of these training programs in coordination with the DILG

III. HACCP AUDIT

Food safety and quality audits are employed widely in the food industry for management
systems evaluation, obtaining certifications to certain food safety and quality standards, assessment
of premises and products condition, confirming legal compliance, etc. The increased interest of
consumers on food safety and quality matters, triggered mainly by recent food scandals, has
enabled the public and private food sectors to develop a variety of food safety and quality standards.
The audit procedure usually incorporates documentation review and conduction of checks and
interviews to confirm compliance with a standard. Traditional inspections evaluate the structure
and construction of the sites and visually assess the state of cleanliness, although these may not
always be the best indicators. The auditing process may involve the inspection of the whole
manufacturing process from a raw material through preparation to service and can be very detailed
and thorough (Griffith 2005). Specifically, within the frame of a food safety audit, information
about a food business is gathered in order to identify areas of potential improvement in the
company’s food safety processes and systems. Audits are very important tools for maintaining food
safety standards and any relevant certification, through enabling transparency and reassuring that
standards are being sustained wherein this transparency can improve the collaborative capacity of
stakeholders within the supply chain, and enhances safety and efficiency, while promoting the
continual improvement within each part of the supply chain (GFSR 2016).

Definition of Audit
 (ISO) Audit Systematic, independent, and documented process for obtaining audit
evidence, and evaluating it objectively to determine the extent to which the audit criteria
are fulfilled Audit criteria Set of policies, procedures, or requirements used as reference
against which audit criteria is compared. Audit evidence Records, statements of fact, which
are relevant to the audit criteria, and verifiable Source: ISO 19011: 2011
 (GFSI) A systematic and functionally independent examination to determine whether
activities and related results comply with a conforming scheme, whereby all the elements
of this scheme should be covered by reviewing the supplier’s manual and related
procedures, together with an evaluation of the production facilities. GFSI Guidance
Document, version 6.2
 (SQF) A systematic and independent examination of a supplier’s SQF System by an SQF
auditor to determine whether food safety, hygiene and management activities are
undertaken in accordance with that system documentation and comply with the
requirements of the SQF Code, as appropriate, and to verify whether these arrangements
are implemented effectively.
A safety audit includes the collection and measurement of data to verify the effectiveness and
reliability of safety programs, employee training, and company systems within a workplace. A
safety audit is executed to determine whether the inspection is providing precise, trustworthy,
complete results. A safety audit is used to check whether the safety programs are implemented and
working properly. The primary difference between an inspection and a safety audit is that a safety
audit also carefully examines and critiques the safety inspection processes. One part of a safety
audit could involve analyzing the schedules used for safety inspections to confirm if they are
comprehensive and relevant to food safety objectives. The audit may also examine whether
inspections are being conducted by the proper personnel, and whether they accomplish the desired
goals. The safety audit also analyzes a location’s comprehensive safety plan, the execution of safety
practices, and whether corrective action is implemented to fix safety hazards and problems.

History of Auditing
Industrial Revolution - During this time, companies realized that there was a need to
develop mechanisms for detecting fraud and establishing financial accountability. As a
result, investors started relying upon financial reports as organizations started joining the
stock market.

In 1929 - Auditing became obligatory in the U.S. Specifically, the Securities and Exchange
Act of 1934 formed the Securities and Exchange Commission (SEC). The responsibilities
of SEC included, among others, the formalization of accounting standards and the formal
establishment of auditor oversight functions. Moreover, the SEC was responsible for
enforcing the mandate that publicly traded U.S. companies would need to periodically
submit a number of reports to the agency within certain time frames. To facilitate the SEC
processes that ensured that these reports were generated following generally accepted
accounting principles (GAAP), public accounting firms were eventually obliged to issue
specific assurances about the information (Byrnes and others 2012).

In 1996 - With regard to the modern standards in the fields of food safety and quality, work
on the British Retail Consortium (BRC) Global Standards first began, when it was accepted
by retailers that there were significant advantages in sharing experience and cooperating in
the development of robust systems. The introduction of the BRC Global Standards was
principally driven by the need to ensure that legislative requirements were met. They were
quickly established though, since their benefits to the suppliers of U.K. retailers started
becoming apparent. What retailers expected were legal, technical, and financial
advantages. The development of the standard aimed at assisting retailers to ensure they
fulfill their legal obligations and to ultimately protect the health of the consumers. Retailers
are legally obliged to take all reasonable precautions and exercise all due diligence to avoid
failure. This can include, among others, the verification of technical performance at food
production facilities of retailer-branded products. The BRC Global Standards aim at
improving supplier standards and offer consistency, while assist in preventing product
failure and reducing the number of audits required to food manufacturers.

20th Century- Finally, the support of the retailer objectives and the provision of concise
information to assist with due diligence defense are also among the reasons why these
standards became so popular (Havinga, 2006). Before the creation of Global Food Safety
Initiative (GFSI) in 2000, the requests for audits from major buyers within the food supply
chain had increased significantly. Different retailers used to apply specific food safety
requirements for different products and suppliers had the obligation to prove that they were
able to comply with all these specifications, mainly through allowing a number of audits in
their facilities. National or regionalized schemes, developed by the industry, such as BRC
and the Intl. Food Safety Standard (IFS) in Europe, allowed, through their wide
recognition, suppliers to conduct just a single food safety audit in order to gain approval
by a number of retail customers (GFSI 2011). The fact that supply chains became
significantly more complex and globalized, highlighted the need for standardized,
internationally accepted food safety plans. GFSI, an international committee founded in
May 2000 and coordinated by The Consumer Goods Forum, responded to this need by
creating a system whereby particular food safety schemes are benchmarked against certain
criteria. A certification to a GFSI-recognized standard, such as FSSC (Food Safety System
Certification) 22000, Safe Quality Food (SQF) Inst., or BRC, provides the necessary
reassurance to customers that a certain level of food safety and quality is established, thus
offering the certified company a beneficial position in the marketplace as a trusted source.
Food safety certification not only increases the efficiency of transactions in the supply
 chain, but also renders the food safety audit process more efficient, by allowing businesses
to significantly reduce the number of supplier audits (GFSR 2016).

The Auditing Process

Technology plays an important role in food safety audits. The maintenance of the necessary
food safety checklists and quality insurance documents requires the management of large amounts
of data. Many organizations categorize their auditing program into: (1) external audits, which are
audits conducted by a third-party organization, and (2) internal audits, which are audits conducted
by internal auditors that work for the organization.

 External Audit - This auditing process involves detailed assessments in which the companies
regularly focus principally on passing the audit. This way of approaching external auditing has
resulted in the conduction of misunderstood or underutilized internal auditing.
 Internal Audit - this auditing process needs to be seen as an important tool of quality management
systems (QMSs) that can contribute to the continuous improvement and validation of the food
safety systems (Driscoll 2012).
Audits can be categorized, based on auditor–auditee relationship, into:
(1) First-Party Audits: A self-assessment, that offers internal verification that procedures and
management strategies meet the requirements of a standard and represent the business
goals/objectives.
(2) Second-Party Audits: Also commonly known as proprietary audits, these audits assess the
performance of supplier s or contractors.
(3) Third-Party Audits: These audits involve the conduction of audits by independent auditors
that are not employed by the auditee and often lead to certification.

Regardless of their type, food safety audits are usually conducted following these steps:

(1) Planning
Planning and preparation of on-site auditing activities should be carried out by the auditors.
These activities may include the preparation of an audit plan or a review of the documented food
safety program of the company, to ensure that it is in compliance with the requirements of the
standard against which the audit will be held. In the case of large and complex companies, an audit
team is required. An audit plan should assist in ensuring that the audit team members are properly
organized and also give the company an idea of timings for the audit. Prior to an on-site assessment,
the auditor should review the company’s documented food safety program to confirm that it is in
compliance with the requirements of the standard against which the assessment will be made. This
can be an indication of whether an on-site audit should follow.
(2) Execution
The execution of audit is the collection of data that starts with arrival at the audit location
and ends with the exit meeting. An on-site audit involves on-site audit-management, a meeting with
the representatives of the company, gaining an understanding of the process and system control
measures, verification that the measures work effectively and communication of results and
observations among team members and with the auditee (ASQ 2013). A process audit is carried
out through performing a review of procedures and documentation, and interviewing members of
the personnel directly involved in the process being subjected to audit.
(3) Corrective and preventive action
The auditor evaluates the responses and decides whether they are reliable and in accordance
with documented policies, objectives, procedures, and records. Inconsistency of responses would
mean that the auditor would have to continue searching for the reasons of the inconsistencies and
find the necessary evidence that support that details. Therefore, audit trails are an important part of
the auditing process. The auditor seeks to identify the reason of the inconsistency and then correlate
it with the management system and a standard, giving the food company the tools they need to
identify and address the inconsistency. The use of this system requires the substitution of the
detailed audit checklist by a less detailed checklist (a memory aid) that aims at simultaneously
assessing various elements of a food safety management system (FSMS) (Surak and Lorca 2007).
According to Westcott (2005), “A corrective action deals with a nonconformity that has occurred,
and a preventive action addresses the potential for non-conformity to occur. The corrective action
process generally involves locating and documenting the root cause of the non-conformities,
scanning the entire system to ensure no other similar nonconformities could occur, analyzing the
effect such as non-conformity may have had on a product or service produced before the
nonconformity was discovered, and taking action consistent to the severity of the situation by either
recalling the product, notifying the customer, downgrading or scrapping product.” It is also of
paramount importance to follow-up with checks on whether any corrections are effective and
recurrence can be prevented. The preventive action process commonly involves the establishment
of proactive measures to prevent a potential nonconformity from occurring, and the conduction of
thorough process and system analysis in order to determine what actions are required and what
controls should be in place to prevent a nonconformity (for example, using Failure Mode and
Effects Analysis (FMEA) to determine risks and possible deficiencies and define priorities for
improving the current system) (Westcott 2005).
(4) Verification
The verification stage of an audit involves the conduction of an assessment that aims at
evaluating how effective the corrective and preventative actions are in achieving their purpose, as
detailed in the management strategy. The individual responsible for conducting the food safety
audit should not be the same individual who determined the corrective action, to add a degree of
impartiality and a 2nd viewpoint. Further verification can be possible through the review of all
collective outputs of a given action, as well as by following up with mini-audits and short
confirmatory interviews (GFSR 2016). It is always imperative that the audit processes used are
reviewed and enhanced at frequent intervals. Furthermore, third-party audits, being only 1
performance indicator, usually need to be supported by microbial testing, second-party audits of
suppliers and the organization’s ability to analyze the results and outcomes of audits and
inspections. None of the raw product suppliers should be excluded from the audit scope. Audit
systems incorporating unannounced visits in combination with supporting information are more
effective and cover internal audits- records, regulatory compliance, laboratory results, and raw
material certifications. Some food businesses employ auditors as direct stakeholders to carry out
internal audits. Other auditors are employed by second-party purchasers or third-party auditing
agencies. There are also buyers that perform their own audits or additional testing, while others
depend on the results of third-party audits. Third-party auditors, though, base their audits on a
variety of food safety standards and the majority of them do not have any involvement with the
products being sold (GFSR 2016).
(5) Audit evaluation
The conduction of audits is carried out under a proprietary standard, while the conduction
of food safety inspections is commonly performed within a legal framework. It is important to note
that there have been many foodborne illness outbreaks associated with food businesses that have
been successful in third-party audits and inspections, which renders the utility of these practices
questionable. People supporting the role of third-party audits claim that they can ensure food safety,
even when the economic resources are limited. People criticizing external audits and inspection,
though, claim that although they are useful tools, their results represent only a snapshot in time
(Powell and others 2013). Albersmeier and others (2009) reported that weak auditing procedures
may be currently used in quality certification systems in the agricultural sector. Not only case
studies, anecdotal information or rumors but also statistical analyses confirm that there are
differences between different certification bodies (auditors). Despite the fact that the results do not
prove that there is any significant reason for the variations presented among certification bodies
and auditors, they still clearly hint at problems and inefficiencies in the control system. It is now
accepted that there can be no guarantees over the validity and reliability of audits, and is therefore
questionable whether third-party certification really achieves its purpose. The standard audited can
greatly affect the way an audit is conducted as well as its outcome. However, another very important
factor in the auditing process is the auditor. The competence degree of an auditor is of paramount
importance and can vary depending on several factors. The personnel responsible for developing
and managing the audit programs should determine in advance the criteria and requirements in
relation to auditors and their competencies (Safefood 360 2013).

Principles of Conducting a Food Safety Audit

HACCP is a food production, storage and distribution monitoring system for identification
and control of food-related health risks. Importantly, one of the goals of an HACCP audit is
preventing food contamination, rather than an evaluating the end product. Therefore, HACCP shifts
the responsibility from food inspectors to food producers to ensure that products are safe for
consumption. HACCP systems are based on guidelines set forth by the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF). This defined the seven principles
below and listed ways an organization can adhere to them:
1. Hazard analysis
List the steps in the production process and identify where significant hazards are likely to
occur. Action: Use a readily accessible, mobile solution to create checklists for identifying possible
safety hazards.
2. Critical control point (CCP) identification
The point at which control can be applied and a food safety hazard can be reduced,
prevented or eliminated. Action: Identify CCPs clearly in your surveys. Encourage and train
employees to properly identify them.
3. Establishment of critical limits
 The maximum and/or minimum value to which a biological, chemical or physical
parameter must be controlled at a CCP to prevent, eliminate or reduce the occurrence of a food
safety hazard. Action: Working with your team, conduct a baseline audit to identify these
parameters. Use these results as a point of comparison for future food safety audits.
4. Monitoring procedures
Procedures must be in place for the measurement of the critical limit at each CCP. Action:
Determine how the measurement will be taken, when it will be taken, how often, and who is
responsible for data collection.
5. Corrective actions
Establish appropriate responses if problems are indicated. Action: With your team, identify
the steps that will be taken when a problem is reported. Determine how you will inhibit potentially
hazardous food from entering your organization’s food chain and how you will correct the process.
Use real-time notifications to quickly inform team members.
6. Verification
Determine the validity of the HACCP plan. Activities in this step may include increased
auditing of CCPs, shipment review, instrument calibration, product testing and record review.
Action: Use a flexible platform that allows you to create separate food safety audits for these
various activities, as needed.
7. Record keeping
Information that will prove that food was produced safely. The records should contain
information about the HACCP plan, hazard analyses and all other procedures. Action: This step
relies heavily on your ability to collect accurate data in the field. Provide employees with an easy-
to-use reporting system for food safety audits, one that organizes data and provides actionable
insights.