FOOD SAFETY ASSURANCE SYSTEMS
Documentation and Record Keeping
RF Stier, Consulting Food Scientist, Sonoma, CA, USA
r 2014 Elsevier Inc. All rights reserved.
Glossary
Critical Control Point A step at which control can be
applied and is essential to prevent or eliminate a food safety
hazard or reduce it to an acceptable level.
Document Any written procedure or protocol that
describes how something is done, demonstrates that a
measurement or observation was made or supports a
program.
HACCP plan A document prepared in accordance with
the principles of hazard analysis critical control points
(HACCPs) to ensure control of hazards that are significant
for food safety in the segment of the food chain under
consideration.
Hazard analysis The process of collecting and evaluating
information on hazards and conditions leading to their
presence to decide which are significant for food safety and
therefore should be addressed in the HACCP plan.
Introduction
It is a law the world over that food, ingredient, and beverage
processors must produce safe foods. Processors develop,
document, implement, and maintain a wide range of pro-
grams to ensure that the foods they manufacture are safe and
wholesome. These programs include prerequisite programs,
such as cleaning and sanitation and pest management, a
food safety management system (hazard analysis critical con-
trol point (HACCP)), quality management, production con-
trol, and food defense programs. The latter are aimed at
minimizing the potential of an act of bioterrorism. Moni-
toring and the records that are the end result of the moni-
toring program demonstrate how effective the system truly is.
Government officials and others have said:
If it is not written down, it never happened.
This directly applies to records, but a proper documen-
tation system is essential for all phases of a food processing
operation. Procedures describe how programs are to be es-
tablished or managed; work instructions provide line workers,
the sanitation crew and others with detailed instructions as
to how a task should be conducted, what records to keep,
and what to do in the event if there is a problem. Forms,
268
Monitoring The act of conducting a planned sequence of
observations or measurements of control parameters to
assess whether a critical control point (CCP) is under
control.
Record Written or electronic information that provides
documentation that status on a procedure, whether an
action has been conducted properly or has been completed
or supports a program. Most records are maintained on
forms designed for that purpose.
Step A point, procedure, operation, or stage in the food
chain including raw materials, from primary production to
final consumption.
Validation Obtaining evidence that the elements of the
HACCP plan are effective.
Verification The application of methods, procedures, tests
and other evaluations, in addition to monitoring to
determine compliance with the HACCP plan.
both hard copy and electronic, provide a means to monitor
and record the activities related to quality, safety, and sani-
tation. These forms are filed as records, which provide a his-
tory that allows the processor, third-party auditors, customers
and potential customers, and regulators to verify that the
system is working as designed. Of course, these same records
may also demonstrate lack of compliance and provide
evidence as to why problems, such as foodborne illness,
occurred.
Food processors are expected to develop many different
programs. Table 1 shows a list of the kind of programs a
processor should have. This is based on what must be done to
ensure quality and safety, and meet the expectations of most of
the third-party audit schemes. Procedures and work in-
structions, if needed, must be developed in each of these areas.
The area, such as cleaning and sanitation, might have a general
requirement for managing the program, plus a long list of
specific work instructions as to how each piece of equipment
can be kept properly cleaned along with floors, walls, drains,
overheads, utensils, and whatever else needs cleaning. All
procedures and work instructions must include the means of
evaluating the activity to ensure that it is done properly and a
form or some other means of recording that the work was
done. The processor must also commit to training the work
force on each procedure, which must be recorded. Training
not only ensures that the worker understands how to do his or
Encyclopedia of Food Safety, Volume 4 doi:10.1016/B978-0-12-378612-8.00373-5
 Food Safety Assurance Systems: Documentation and Record Keeping 269

Table 1 Records required for a food safety management system Developing a Document-Control Program
Document/program title
Each and every processor should make a commitment to
1. Organizational Chart developing a document-control program. This program will
2. Quality Manual: Mission & Quality Policies help ensure the following.
3. Stakeholders List
1. Procedures and work instructions are developed using a
4. Communication Guidelines – Internal/External
standard format.
5. Food Safety Committee/HACCP Team
6. Master Cleaning Schedules 2. All documents and forms are subject to a review process
7. Cleaning Procedures before being put into use in the facility.
8. Ingredient Shipping & Receiving Procedures & Records 3. Only current protocols and forms are used.
9. Specification Manual: Ingredients, Packaging & Finished Goods 4. Old or outdated documents are removed from circulation.
10. Letters of Continuing Guarantee (COA) 5. A record of how protocols have evolved is maintained.
11. HACCP Program 6. There is an updated master list of all procedures, work
12. GMPs instructions, and forms used in the facility.
13. Allergen Program 7. Documents and records are protected from damage and are
14. Consumer Complaint Program
secure.
15. Recall & Traceability Program
16. Non-Conforming Products Procedures
The processor should also appoint someone to manage
17. Regulatory Inspection Program
18. Processing SOPs & Record Keeping the document-control program. This could be someone
19. Change Control Procedure from the quality group or it could be someone whose title
20. Process Deviation Procedures & Log is simply Document Control Manager. This person’s job is
21. Internal and External Audit/Inspection to manage the program. He or she need not be a technical
22. Product Testing person, unless part of their job description will be to review
23. Vendor Approval Program procedures, work instructions, and forms for content. If this
24. Glass & Brittle Plastic Program is the case, someone with a technical background should
25. Preventive Maintenance Program: Including Emergency Repairs be assigned to manage the program. If a company does not
26. Pest Control Program
have a document-control program, the Document Control
27. Sampling Procedures
Manager will be responsible for developing the program
28. Environmental Monitoring
29. Metal Detection Program incorporating the elements noted earlier. If the program
30. Foreign Material Detection is already established, their task will be to manage the pro-
31. Shipping and Distribution gram. He or she will also be responsible for developing a team
32. Receiving Programs to review and approve documents. Some companies assign
33. Calibration Procedures responsibility for creating documents to specific persons
34. Retain Samples Program in each operating group, whereas others allow anyone to do
35. Water Quality Program so provided they follow the procedures that have been
36. Warehousing and Storage established.
37. Food Defense: Security Assessment & Plan
Each company has their own format for creating docu-
38. Corrective and Preventive Actions (CAPA)
ments. There are, however, elements that are common to
39. Legal Requirements: File of Laws & Regulations
40. Education and Training most. These include

1. Title – What is the name of the procedure, work in-

her task safely and effectively, but it also protects the company
and the worker. In an increasingly litigious world, failure to
properly train workers could be deemed negligence if there is
an injury or foodborne illness.
So, a well-managed document program will provide a large
number of benefits to the company.
1. It describes how work should be done.
2. It provides a record that the work was done.
3. It provides materials to verify that the system is working.
4. It provides evidence when the system is not working.
5. It provides evidence that corrective actions were taken.
6. It provides support that the programs are properly designed
(validation).
7. It provides evidence that workers are trained and
competent.
8. It protects the business, employees, and customers.
struction, or form?
2. Objective – What is the program supposed to do and
why?
3. Procedure – How is the protocol to be done? This step
provides the details and establishes expectations. It would
also include information such as tools required, personal
protective equipment (PPE) required, safety issues and re-
quired records, and how they should be monitored. If a
specific form is required, that form should be referenced
and even attached to the procedure itself.
4. Responsibility – Who is responsible for managing this area
or doing the work described in the protocol.
5. Corrective actions – What should be done in the event
that there is a problem, a critical factor is not achieved or
the evaluation is unsatisfactory.
6. Footers – Many forms will also include information such as
the date when the form was generated, a tracking number,
revision number, who created the document, and who
signed off on it.
270 Food Safety Assurance Systems: Documentation and Record Keeping

Other sections that may be included are a scope, key words,
and references. Some companies like to refere other procedures,
supporting documents, or regulations in their procedures.
The format is really up to each individual operation.
All of the procedures, work instructions, and forms should
be entered into a Master List, which is updated as required.
Headers in the Master List might include the document title,
the number, creation date, last revision date, document
number, department, and who created the document. All
materials can be kept in one Master List, but for many com-
panies, it is often easier to maintain separate lists for each
department.
Another element that needs to be established is how to
ensure security if the procedures and forms are maintained in
electronic files. The Document Control Officer will need to
work with the computer group to establish passwords, estab-
lish levels of access, and ensure that the system is backed up
and protected.
Procedures and Work Instructions
Procedures and work instructions provide the road map for
plant operations. They should be written so they clearly in-
form management and staff how things should be done, when
things should be done, and how to document the work. These
documents also form the basic for training and for internal
audits. Auditors, both internal and external, must watch dif-
ferent operations to determine whether procedures are being
followed as written. When an external auditor sees that one
procedure is not being followed, he or she will often dig much
deeper. They will assume that there are others that are
in doubt.
As noted earlier, procedures often describe the expectations
of a program, whereas the work instructions define how the
tasks within the program shall be performed.
Table 2 shows a procedure for a glass and brittle plastic
program. This procedure includes all the elements expected

Table 2 Sample format for procedures

Subject: Glass and brittle plastic program

Objective: Minimize the potential for crosscontamination of foods and ingredients with glass or brittle plastic to ensure that foods and ingredients are
safe and will not result in injury to end users.

Procedure:
1. It is a company policy that there shall be no glass or ceramics carried into or used in the food processing area or warehouse at any time. Glass
and ceramic shall be confined to the offices and break area. Watches must be removed before entering the plant. Eye glass lenses shall be
manufactured from shatterproof materials.
2. Windows in production or warehouse areas must be shatterproof or coated/covered with plastic to contain breakage.
3. Inventory all glass and brittle plastics in areas where foods and ingredients are stored or handled. This includes the warehouse, production, and
packaging areas. When conducting the inventory, note location of glass or plastic, the type of glass or plastic (if possible) and whether it is
shielded or strengthened in any way. This inventory must also include the area or areas where glass is stored.
4. Transfer all information gathered in step #1 into a Master List.
5. Plant Management shall then examine the Master List for glass and brittle plastic and determine whether any of the situations existing within the
plant pose a realistic threat of contamination and potential injury.
6. The potential risk (high, medium, low) shall be noted in the Master List with the date(s) of review.
7. Situations that pose a realistic threat (high) shall be addressed as soon as possible and corrective actions noted in the Master List. Corrective
actions may include but need not be limited to the use of shields of covers, replacement with stronger or shatterproof plastics, or removal of the
situation from the production or holding area.
8. The company shall establish a regular audit program to examine all glass and brittle plastic noted on the Master List to determine its condition. If
any breakage is noted, it shall be noted on the Master List and repairs made immediately.
9. Employees shall be trained to report any broken glass or brittle plastic such as cracked gage covers or windows.
10. Whenever glass must be transported through the plant, it must be protected and contained in some way. For example, lights must be carried in
their original box when being moved for replacement.
Responsibility: Production supervisor
Corrective actions:
a. Glass and brittle plastic breakage and cleanup
If glass or brittle plastic breaks in the production area or warehouse, operations shall cease immediately.
b. All exposed product shall be segregated and placed on hold.
c. Workers in the area of the breakage shall not move throughout the plant so as not to spread the glass and brittle plastic through the plant.
Shoes shall be inspected before leaving the area and cleaned if needed.
d. Broken glass and brittle plastic shall be cleaned using designated tools and disposed of into designated containers.
e. Glass and plastic breakage shall be recorded in a Glass and Brittle Plastic Breakage Log. This shall note the type of breakage, the location,
whether any product was affected and the disposition of said product.
f. Plant Management shall meet to discuss all incidents, determine the cause and implement a corrective/preventive action plan to minimize the
potential for future incidents.
g. Discovery of damaged or broken glass or brittle plastic
If cracked, damaged, or broken glass or brittle plastic is observed during audits, internal inspections or routine examinations of operations, it must
be noted and evaluated immediately. Repairs shall be prioritized based on potential risk to the business.
h. These incidents shall be recorded in the Glass Breakage Log.
 Food Safety Assurance Systems: Documentation and Record Keeping
from a glass and brittle plastic program. There are elements in
this procedure that would require additional information.
Work instructions for how to develop the glass and brittle
plastic register, how to establish the degree of risk for each
item on the register, and how often internal inspections
should be done are not defined. These points need to be
established and documented in a separate work instruction.
There should also be procedures detailing how the glass
breakage log should be establish and utilized.
From a food safety perspective, it is especially important
that the work instructions that are developed for monitoring
critical control points (CCPs) are clearly written and that
they reference the record-keeping forms. Those responsible for
monitoring should:
• be trained in CCP monitoring techniques, (company must
document training and competence),
• fully understand the importance of CCP monitoring,
• have ready access to the monitoring activity,
• accurately report each monitoring activity,
• immediately report critical limit infractions so that imme-
diate corrective actions can be taken, and
• understand the corrective and/or preventive actions that
must be taken.
The procedures for doing the work need to be clearly
written. Forms for monitoring should be simple to use, pro-
vide a space for entering the information being monitored,
and an area where the operator can sign the form. It is a good
idea to include the critical limits on the monitoring form so
that information is easily accessible.
Not all records are done manually. Even if the records are
continuously recorded on a chart or data are entered into an
electronic system, there must be procedures for how the work
is to be done.
One of the best tools that food processors can use
when developing good, easy to use procedures is the digital
camera. Incorporating pictures of instruments, equipment,
or gages can help clarify procedures and minimize the
potential for them being misunderstood. Pictures can also be
used to emphasize what are good practices and what is un-
acceptable. As an example, most food processors have basic
requirements for hair restraints, garments, eye protection,
ear plugs, and other gear. Many facilities are seen that post
pictures in their locker rooms or at the entrance to the plant
to show workers what is and what is not acceptable. But the
best use of photographs is with equipment operation. Many
operations utilize startup checklists that provide the operators
with step-by-step actions to follow and information that
must be recorded. Using photographs reinforces the protocol
and is an invaluable tool when it comes to training new
operators.
As noted, forms should be considered controlled documents
and should be included in the document-control program.
There are a wide variety of forms that are used throughout the
industry. There are several elements that should be part of each.
These are
• form title,
• firm name and location,
• area to enter the time and date,
271
• product information (including product type, package
size, processing line, and product code where applicable),
• area for actual observations or measurement,
• critical limits,
• area for operator’s signature or initials, and
• space for reviewer’s signature or initials, and date of
review.
If a company has forms that they are using do not have a
space for reviewer’s signature and date, a stamp may be used
with spaces for the entries.
One thing that should never be done is to print forms
with preprinted information, such as time. The operator must
enter the time, and when the measurement, or reading was
made. It should not be on the form. In the reality of the
production environment, record keeping is not done every
hour on hour.
Monitoring and Record Keeping
Monitoring records are the heart of the HACCP program.
Monitoring records show the following:
1. that the system is in control,
2. that the system may be going out of control, and
3. that the system has lost control.
As noted earlier, persons monitoring CCPs must be trained
on the procedures and fully understand the importance of
monitoring. This applies not only to persons doing moni-
toring CCPs, but also to all responsible for monitoring pre-
requisite programs, production operations, and any other
element of the quality, safety, and sanitation program. They
are all part of the food safety management system (FSMS).
One set of documents that each processor must maintain
are calibration records for all instruments or equipment used
to monitor CCPs, plus protocols for how these instruments or
pieces of equipment are to be calibrated. The procedures for
calibration must include how to do the work, who is re-
sponsible for doing the work, the acceptable tolerances and
corrective actions to be taken in the event if an instrument or
equipment is found to be out of calibration. The corrective
actions must examine whether any food has been affected by
an instrument that is out-of-calibration and describe what
should be done with any affected foods.
There are basic requirements for how records should be
kept. Many companies mandate that monitors use only blue
or black pens to record information and go so far as to define
what kind of pen is safe to use in the processing area. They will
also define how corrections should be made.
‘‘If operators make an error on a form, the error shall be
noted by lining out the incorrect entry, inserting the proper
result and initialing and dating the change’’ (Figure 1).
The procedures should state that corrections cannot be
made by erasing an entry, the use of liquid paper, or tape. In
the eyes of the regulators, these would be falsified records
(Figures 2 and 3).
Monitors must also be taught that there are some things
that they should never do. Many persons charged with
monitoring will use entries such as ditto marks or lines to
272 Food Safety Assurance Systems: Documentation and Record Keeping
indicate that the numbers are the same (Figures 4 and 5). This
is unacceptable. Records have to be recorded at the time they
were measured or observed. Ditto marks or lines drawn down
the page do not provide that information. This is why forms
with preprinted data are unacceptable.
Corrective Action Records
If monitoring shows a deviation at a CCP, the product in
question is deemed to be unsafe or potentially hazardous. The
processor must now take corrective actions to bring the system
back into control and make a disposition of the product that
was affected. Records of all actions to evaluate the deviation
and dispose of the product must be maintained.
Corrective actions records must be maintained for all
quality and prerequisite monitoring activities. In many cases,
a corrective action may be noted on the record-keeping form.
As an example, if a processor was using adenosine tripho-
sphate (ATP) swabs to verify the efficacy of cleaning and a
swab indicated that an area was not clean, the sanitation
supervisor could record the swab results and the results
from retesting after the suspect area was recleaned. In this case,
Figure 1 Properly corrected record: cross out, date and initial.
Figure 2 What not to use when correcting records.
the corrective action would be captured on the original
monitoring form.
Corrective actions and records of these actions are one
of the most common failings in food processing plants. All too
often, the processor makes a correction but fails to document
that it was done. They fail to close the loop. Failures to con-
duct corrective actions are very common when evaluating
records of prerequisite programs. As an example, the pest
control operator observes that a door is broken and does not
fit tightly. He notes it on his report and the plant fixes it, but
the plant fails to record that this issue was closed on the report
or elsewhere.
It is expected that all deficiencies on internal audits, rou-
tine audits, and third-party audits will be addressed and there
will be corrective action records of all actions taken to fix the
problem. The quality group should verify that the work was
completed properly by signing off on the corrective action
report or in the corrective and preventive action (CAPA)
logbook.
For routine corrective action issues, such as properly
cleaning a piece of equipment or making a repair, how these
issues are addressed is quite simple. They are simply cleaned
or fixed. However, if there is a significant problem, such as a
Figure 3 Improperly corrected record: Liquid Paper and tape.
 Food Safety Assurance Systems: Documentation and Record Keeping 273

Improper Record

Figure 4 A sample of improper records.

Improper Record

Figure 5 A sample of improper records.

274 Food Safety Assurance Systems: Documentation and Record Keeping
major deviation at CCP or a serious quality issue, the cor-
rective action program and how it is documented becomes
more complex. Again, how these issues are addressed must be
defined in the procedures. With complex issues, the processor
should define the problem, develop a written corrective action
plan, create a time line, and move forward on the activity.
When the work is done, they will notify the quality team who
will then review the records and the results and approve or
disapprove the work. Depending on the type of problem, they
may recheck the issue at a later date to verify the actions were
successful. Again, this must all be documented.
One tool used by many processors is a CAPA logbook. This
may be retained as a hard copy or electronically. This log
serves as a reservoir for all issues that required corrective
actions and is used to track progress. Electronic logs seem to
be more popular as they allow the quality group to easily track
the status of corrective action activities. They can see what
has been done and what is still pending. In addition, a well-
designed electronic log allows problems to be sorted and high
priority or regularly occurring issues can be addressed at
greater length. The CAPA log is something that the HACCP
team should review each time they meet.
Record Review
One of the seven HACCP principles is verification and part of
verification is ensuring that all CCPS have been properly
monitored. Food processors must be sure that a member of
the management team has been trained to review all records of
CCP monitoring. Ideally, this review should take place before
the product is shipped. The reviewer must examine the
monitoring records, be sure that the values are correct, and
that they have not only been filled out properly, but were also
signed by the monitor.
All calibration records, especially those done on instru-
ments used to monitor CCPs, should also be reviewed on a
regular schedule. Most companies will conduct such a review
at intervals ranging form a week to a month.
The reviewer must sign and date the records following
his/her review. If a space has not been provided for a signature
and date, the stamp mentioned earlier may be used. It is also
acceptable simply to sign and date the records.
Procedures should be drafted that describe how records
should be reviewed and what should be done if deviations are
observed. This is especially important when reviewing more
complicated records such as those required for the production
of low-acid foods. There may be many CCPs for such records.
In addition, there may also be several different pieces that will
require review. As an example, there may be the operator retort
record, the recorder chart printout, and seam integrity records.
All need to be carefully examined and issues highlighted.
Many companies bundle their daily production records
and require that their quality personnel review all the records
in the bundle, that is, food safety, quality records, and sani-
tation records. Processors who utilize this kind of procedure
usually attach a cover sheet to the bundle listing all the re-
quired records that must be in the packet and are subject to
review. The absence of a record would then be considered a
deviation. The completed packet should include evidence that
each record in the packet was not only present, but was also
reviewed.
There are other situations where documents and records
are subject to review: third-party audits and regulatory in-
spections. Each and every third-party audit, whether it is a
company-owned system or one of the six schemes approved
by the Global Food Safety Initiative (GFSI), entail review of
procedures and records, plus evaluation of how the protocols
are actually implemented. With these audits, all procedures,
work instructions, and all kinds of records are subject to
examination. The six schemes currently approved by are the
British Retail Consortium (BRC), International Food Standard
(IFS), Dutch HACCP, Safe Quality Foods (SQF), FSSC 22000,
and Synergy 22000. The most stringent of all the food safety
audits is that for International Organization for Standard-
ization (ISO) 22000. Companies who make the commitment
to meet the ISO 22000, FSMS are usually looking at 12–18
months preparation at a minimum, plus an intensive audit by
the certifying body of up to 5 days.
Regulatory investigations also include review of records. The
records that are available for review depend on the type of in-
vestigation and what the company is manufacturing. For ex-
ample, in the US, there will be many more records available for
review for a processor of low-acid foods than there would be for
a manufacturer of soft drinks. Food processors need to under-
stand which records the regulators are allowed to access and
which are not. With the passage of the Food Safety Modern-
ization Act of 2010, HACCP will become mandatory for food
processors in the US. These records and others will, therefore, be
accessible to regulators.
Therefore, since documents and records are an integral part
of both third-party audits and regulatory investigations, it
behooves a processor to properly develop, implement, and
maintain these materials.
Record Storage and Retention
An integral part of the document-control and record-keeping
program is storage and record retention. All records must be
stored in a secure (locked) area where they are protected from
water damage, fire, pests, and theft. Some companies have
actually constructed what amounts to block houses for record
storage. These facilities are built in a warehouse of cinder
blocks and brick with a sturdy roof. They are air conditioned
and have fire abatement systems; systems that rely on chem-
icals not water. The records themselves are filed in locked
cabinets in the area and the companies adopt checkout sys-
tems if anything is taken out of the area. The document-
storage areas are usually built with a reading room, so records
can be viewed within the secure area. The storage facilities at
most plants are nowhere near this elaborate.
There are also many companies that are turning to firms that
will store documents for them off site. There are, however,
regulations that mandate how long certain regulated products
must retain records on site. These operations have all the features
noted earlier. They also manage their files so that they can access
things quickly and easily. If the processor contacts them and asks
for specific records, they can usually be located and delivered
within 2 h. The record storage companies will also notify the
 Food Safety Assurance Systems: Documentation and Record Keeping
processor when the records are scheduled for destruction. When
they get approval to move forward, they will destroy those re-
cords scheduled for destruction and provide the processor with
documentation that verifies which records were destroyed.
This leads to another requirement for records. How long
should they be kept? The juice HACCP regulation in 21 CFR
Part 120. 12 (d) states the following:
(d) Record retention. (1) All records required by this part shall be
retained at the processing facility or at the importer’s place of
business in the United States for, in the case of perishable or re-
frigerated juices, at least 1 year after the date that such products
were prepared, and for, in the case of frozen, preserved, or shelf
stable products, 2 years or the shelf life of the product, whichever is
greater, after the date that the products were prepared.
Records for low-acid canned foods must be retained for
3 years; one of which must be on-site.
For products that are not regulated, one rule of thumb is that
records should be maintained for the shelf-life of the product,
plus 1 year. When determining how long to keep records,
companies need to talk to their clients and the legal department.
Processors who do contract packing are often required by con-
tract to keep process records for longer periods of time.
Electronic records must also be protected and should be
subject to the same storage requirements as hard copies.
All these protocols that describe how records are stored must
be documented in a procedure. The basic procedure must de-
scribe storage requirements, retention times, and mandate that
the records be destroyed at the end of the retention time, and
that records be maintained of this action. In addition, if a
company elects to store records off-site, there should be a pro-
cedure that describes the basic requirements for an outside
storage facility, how the storage firm is selected, and what is done
to monitor their performance.
What is Required for Food Safety
As this article has shown, there are many different records that
make up the food safety management system. These include:
• HACCP plan and support documentation used in de-
veloping the plan,
J Meeting minutes,
J Technical references,
• Records of CCP monitoring,
• Records of corrective actions,
• Records of verification activities,
J Including validation data and internal audits,
• Calibration records,
• Prerequisite programs,
275
J Cleaning and sanitizing,
J Hand sanitizers,
J Any that have been determined to affect product safety
in the company’s hazard analysis, and
• Training.
There must also be procedures or work instructions that
describe how each and every one of these tasks must be done.
Without road maps provided in these protocols, it is simply
not possible to ensure that the work is done properly nor is it
possible to properly train new employees.
Is this a great deal of work? Of course it is, but consider the
alternative: food, ingredient, or beverage that makes someone
sick or causes an injury. One such incident will cost more in
terms of money, headaches, and loss of face than what went into
developing, implementing, and maintaining the program.
See also: Food Safety Assurance Systems: Audits of Food Safety
Management Systems; Essentials of Crisis Management; Hazard
Analysis and Critical Control Point System (HACCP): Principles and
Practice; Investigation of Incidents in Industry; Labeling and
Information for Consumers; Management of Allergens in Food
Industry; Microbiological Testing, Sampling Plans, and
Microbiological Criteria; Recall Systems and Disposal of Food.
Institutions Involved in Food Safety: International Organization
for Standardization (ISO). Public Health Measures: Modern
Approach to Food Safety Management: An Overview
Further Reading
Codex Alimentarius (2003) Recommended International Code of Practices, General
Principles of Food Hygiene, CAC/RCP-1–1969, Rev. 4 (2003).
International Organisation for Standardization (2005) ISO 22000: Food safety
Management systems – Requirements for any Organization in the Food Chain.
Geneva, Switzerland: ISO.
Mortimore S and Wallace C (1994) HACCP: A Practical Approach. New York, NY:
Chapman Hall.
United States Food & Drug Administration (1989a) Title 21, Code of Federal
Regulations, Part 113, Thermally Processed Low-Acid Foods in Hermetically
Sealed Containers. Washington, DC: U.S. Government Printing Office.
United States Food & Drug Administration (1989b) Title 21, Code of Federal
Regulations, Part 114, Acidified Foods. Washington, DC: U.S. Government
Printing Office.
United States Food & Drug Administration (1995) Procedures for the safe and
sanitary processing and importing of fish and fishery products, Code of Federal
Regulations, Title 21 Parts 123 and 1240, December 18.
United States Food & Drug Administration (1996) Current good manufacturing
practices in manufacturing, packing and holding human food, Code of Federal
Regulations, Title 21 Parts 110, December 18.
United States Food & Drug Administration (2001) Hazard Analysis Critical Control
Point: The safe and sanitary processing and importing of juice, Code of Federal
Regulations, 21 CFR Part 120. Federal Register 66(13): 6137–6202.