CHAPTER 6

AUDITING CONCEPTS AND PRACTICES

CQB
CFB 20804
30302 Food Quality
QUALITY & Standard
MANAGEMENT Legislation
SYSTEM IN FOOD INDUSTRIES
Type of Audits
Manufacturing audits
Product manufacturing audits
Manufacturing Audits
These encompass a broad evaluation of the overall
manufacturing processes within a facility or
company.
They involve assessing various aspects such as
facility conditions, equipment maintenance,
employee training, adherence to regulatory
standards, documentation, quality control measures,
and safety protocols.
The goal is to ensure that the manufacturing
operations as a whole meet established standards and
comply with regulations across all products
produced.
Manufacturing Audits
OBJECTIVES OF PROCESS CONTROL
An effective program of process control aims
to:
Manufacture a product that consistently
meets specifications
Ensure that only acceptable products are
released from each step of the overall process
Favour improved stability
Reduce variability in the processing steps
and in the final product
Education and Training
Personnel capability to accurately
implement the process control procedures
is critical to the success of the program.
Personnel must be trained to perform the
assigned process control activities.
In many instances, this requires formal
training in principles and practices, along
with relevant engineering, statistical,
analytical, instrumental, or related
procedures.
Education and Training
A record of the training program should
be maintained to identify the
knowledgeable and capable staff of
performing a designated process control
activity.
 The plan should also include provisions
for upgrading personnel training
whenever equipment or instruments are
updated or new procedures are
introduced.
 Such a program will ensure that
employees are able to keep up with
technological progress.
PROCESS CONTROL DOCUMENTATIONS

The document serves as the basis for planning

process control activities and should include:
Instructions and procedures for products
production
Procedures for process monitoring and inspection
Characteristics to be measured
Procedures for measurement (frequency, time,
place, personnel) and methodology to be used
Procedures for sampling, identification of
samples, and analysis of the data obtained from
the measurements
UNIT OPERATIONS IN THE FOOD
INDUSTRY
 A unit operation is defined as the operation of a piece
of equipment or equipment system that accomplishes
some specified function on the product being processed
and is typically labeled by the function it accomplishes.
 Some of the unit operations commonly found in food
processing are batching, heating, cooling, blending,
pasteurization, sterilization, freezing, evaporation,
dehydration, fermentation, distillation, extraction,
separation, etc.
 For any unit operation, a wide variety of different types
of equipment and systems can be used, depending on
the specific nature of the product being processed.
Unit operations may include numerous
different activities.
Mixing, for example, includes agitating,
beating, internal diffusing, dispersing,
emulsifying, homogenizing, kneading,
and whipping.
Food processing is the selection and
combination of unit operations into unit
processes and more total processes.
Unit Operation List
 Materials Handling
 Cleaning
 Separation
 Disintegration
 Pumping
 Mixing
 Heating
 Cooling
 Evaporating
 Drying
 Packaging
 Controlling
Unit Operation in Operation
PRODUCT
MANUFACTURING
AUDITS
PRODUCT MANUFACTURING
AUDITS
The purpose of a product manufacturing audit is to
verify that all of the general conditions for the
manufacturing of food in a processing plant are
met.
◦ Assuring that the procedures reflect actual practices
◦ Uncovering inaccuracies so that they can be quickly
corrected
◦ Determining the consistency of a process (from person
to person, or day to day)
◦ Demonstrating a proactive approach to process
improvement
◦ Encouraging ongoing corrective action
AUDITS
◦ Manufacturing audits are not meant to catch
people doing something wrong.
◦ A manufacturing audit is more than just
walking into a working area, looking for
problems; on the contrary, during an audit it is
expected to find people doing things right.
Planning the Audit
An audit plan should identify:
The purpose and scope of the audit
The auditee and organisational units to be
audited
The audit team members
The standard being audited against (specific
sections of the standard may be included)
Logistic issues such as the date and place of the
audit, the expected duration of the audit, and
the expected date of issue of the audit report
Planning the Audit
In addition, when applicable, the audit plan may list
confidentiality requirements, transportation requirements,
or required health and safety permits or security
clearances.
A product-manufacturing audit is a comprehensive
inspection of a manufacturing process to determine if it is
performed satisfactorily, under normal day-to-day
operation.
The audit is usually limited to a small portion of units
produced, but the manufacturing processes involved are
reviewed horoughly.
An audit does not replace normal QC efforts, but rather
supplements them.
Planning the Audit
A manufacturing process is audited by
direct observation of the manufacturing
“in-site,” and by auditing the records of
the procedures maintained by the plant.
This is done because the records
contain detailed information of the
manufacturing process; they specify not
only what work is to be accomplished
but also where and who is doing it.
The auditor should also have access to
the manufacturing and analytical
records for the work being carried out.
Planning the Audit
There are many reasons for conducting a
product-manufacturing audit. Among these
are:
 Assuring that the procedures reflect
actual practices
 Uncovering inaccuracies so that they can
be quickly corrected
 Determining the consistency of a process
(from person to person, or day to day)
 Demonstrating a proactive approach to
process improvement
 Encouraging ongoing corrective action
PLANNING THE AUDIT

The following steps help in planning and conducting an

audit.
Select the manufacturing process to
audit
It may be best to begin with a relatively
efficient process with a successful history.
However, it may be preferable to jump
right into a process that has had a record
of ongoing performance problems.
Decide who will conduct the audit
Ideally, the audit team should be made up
of individuals who have audit experience
and are also generally familiar with the
process to be audited.
Decide the frequency of the audit
It should be decided how often members
of the audit team will observe the process.
The more nonconformances discovered,
the more frequent the observations, until
such a level of confidence is gained that
the observations can be scaled back.
Record the audit schedule on a form
Audit times should be as random as
possible and scheduled throughout an
entire shift.
A written record of this schedule should
be distributed to each member of the audit
team.
Conduct the audit according to the audit
schedule
Once you make the permanent schedule,
it should be followed.
This requires a commitment from
everyone involved with the process.
Document problems discovered
This becomes the permanent record and
the basis for all follow-up actions.
Inform all those affected
 While on the site, inform the manager and the
supervisors of the results of the audit so that critical
deviations are corrected as soon as possible.
 Ideally, not only should the employees working in the
process be informed of the audit results, but all
employees affected by the process's performance should
also be notified.
 This will ensure that everyone is aware of problems
discovered and may generate additional suggestions for
improvement.
 However, this decision is up to the plant’s management
personnel; they may decide to review the results with the
employees in a different manner.
Monitor corrective action results
Observe the corrective action to
determine if it eliminated the problem.
Auditing is a proactive effort to ensure a
manufacturing process is controlled.
Auditing also indicates a willingness to
go beyond the status quo and commit to
continuous improvement.
Audit: Documentation Required
Product-Specific Manufacturing (PSM)
Procedures
General Manufacturing Procedures
Product-Specific Manufacturing (PSM) Procedures

This document directly addresses the

manufacturing procedure of a given product,
specifically establishing the processing
parameters at each stage, referring to:
General Manufacturing Operation (GMO)
documents when these are required for handling
or
QC procedures, and Quality Control
Analytical Methods (QCA) when these are
required for analysis of the product at any given
processing step.
General Manufacturing Procedures
These documents describe a certain
activity related to the manufacturing
process of a specific product.
They are used in conjunction with the
prescribed manufacturing document to
control the manufacture of the product.
General Manufacturing Procedures
They address different aspects of the total
manufacturing process, for example:
The Can/Glass Container Packaging
Document addresses the procedure by which
a product is canned, labeled, and coded, and
the container handled, to the warehouse, so
as to preserve intact quality.
The Weight Control Document addresses the
procedure for determining the net weight of
the product during manufacture.
Standard Sanitary Operation Procedures
Sanitation Standard Operating Procedure
(SSOP) documents describe the
procedures that must be followed to
ensure that cleaning and sanitation
activities are performed correctly.
Analytical Control Procedures
These methods can be used, as such, or
adapted to the company’s needs, as long
as the variations do not affect their
accuracy and replication when used
against the official version and have been
tested and checked by collaborative
studies with other laboratories.
Product-Dependent
Operations
Refer to the processes and activities
required to produce a particular food
product.
These operations can vary widely
depending on the type of food being
produced and the specific requirements of
that product.
Processing and packaging:
This involves preparing the raw materials
for the food product, such as washing,
cutting, or cooking.
The food may be packaged in containers
or bags and sealed for freshness.
Mixing and blending
Many food products require various
ingredients to be mixed and blended to
create the final product.
This can involve using specialised
machinery or equipment to ensure that the
ingredients are thoroughly combined.
Temperature control
Certain food products require specific
temperature controls during processing
and storage.
For example, dairy products need to be
kept at a consistent temperature to prevent
spoilage.
Quality control
Quality control measures are taken
throughout the production process to
ensure that the final product meets
specific standards.
This may involve testing the product for
taste, texture, appearance, and safety.
Sanitation and cleaning
To ensure that the food product is safe
and free from contaminants, it is essential
to maintain a clean and hygienic
production environment.
This includes regular cleaning of
equipment and surfaces and adhering to
strict sanitation protocols.
Unit Operation in Manufacturing
Operation
Example of batching operation
Example of batching operation
Product-Independent Operations
Refer to processes that are not directly
related to the production of a specific food
product.
These operations are typically focused on
providing support services to food
manufacturers, such as packaging,
warehousing, transportation, and
distribution.
Warehousing and Storage
This involves the storage of raw
materials, ingredients, and finished
products in a safe and controlled
environment.
Warehouses may also offer inventory
management, order processing, and
product handling services.
Transportation and Logistics
Transportation and logistics services are
crucial for moving raw materials,
ingredients, and finished products from
one location to another.
This may include services such as
trucking, shipping, and air cargo.
Quality Control and Assurance
Quality control and assurance operations
involve ensuring that food products meet
industry standards for safety, quality, and
freshness.
This may include testing, inspection, and
certification.
Research and Development
Research and development activities in
the food industry involve developing new
products, improving existing products,
and exploring new production methods.
This may include testing new ingredients,
developing recipes, and exploring new
food trends.
Packaging
Packaging operations involve the design,
production, and labeling of product
packaging for food manufacturers.
This may include packaging design,
printing, labeling, and filling.
MANUFACTURING
PROCEDURE
DEVIATIONS
Risk Deviations
The manufacturing process includes
certain points or requirements that are
considered quality risks if not carried out
as required in the manufacturing
document and in the GMO documents.
Analytical tests are, by definition, risk
requirements.
Risk Deviation
Risk deviations are defined as
manufacturing process practices that deviate
from risk requirements or practices that
could result in the production, nondetection,
or prolonged manufacture of a product not
meeting its quality objectives.
Risk deviations could include deviations
from specified process parameters,
formulation, testing frequency, and from test
methodology.
Risk Deviation
When test methodology is a risk
deviation, it is reported relative to the unit
operation for which the test is required, as
well as from the test methodology quality
management area.
Nonrisk Deviation
Nonrisk deviations are manufacturing process
deviations not categorised as risk deviations in
the manufacturing procedure document, or
substitute procedures used by the plant.
Provided that the procedure is not likely to result
in the production or nondetection of an off-
quality product or decrease in safety.
If appropriate, the auditor should recommend
substitution of such procedures in the
manufacturing document to reflect actual
manufacturing practices.