“...management must assess the food hazards
The FDA regulations on Good Manufacturing Practices state the following:
Wearing, where appropriate, in an effective manner, hairnets, headbands, caps, beard
covers or other effective hair restraints.
Thus, looking at the ISO 22002-1 and
FDA regulations, there are no prescriptive requirements for what practices
should be used. Best practices typically
state that hair restraints should be worn
at all times and that there should be a
defined policy for beard and mustaches.
If a company has a policy that deviates from best practices and an auditor
questions a policy, the auditor does not
want to hear responses such as:
• This is a low-hazard food.
• This is a low-risk process.
• What about the eyebrows?
If the company wants to deviate from
the best practice or wants an exclusion
from a practice, a hazard analysis should
be prepared to justify the position. The
following items need to be considered in
the hazard analysis:
• What is the potential for product
contamination with a food hazard?
• How is the product protected?
and develop strategies to control the hazard to
an acceptable level...”
What are combination control meas-
Validation, Verification and Monitoring
ures or what are the alternative
How robust are the existing control
How effective are the control
Are there any concerns?
What is the reasoning for the
What are the current best industry
practices? Are there multiple best
Is there any chance for food safety to
Will exclusion in one part of the site
affect the environment for food
safety and affect the potential for
food safety in other parts of the site?
The hazard analysis needs to show
Validation, verification and monitoring are three terms that many food safety
practitioners do not fully understand. ISO 22000 defines these activities in the
Validation is obtaining “evidence that
the control measures managed by the
HACCP plan and by the operational PRPs
are capable of being effective.” Validation
is normally conducted prior to operating a
Verification is “confirmation, through
the provision of objective evidence, that
specified requirements have been fulfilled.” Verification is done during or after a
process has been performed.
Monitoring involves “conducting a
planned sequence of observations or
measurements to assess whether control
measures are operating as intended.”
Many PRPs cannot be easily validated.
Instead, most PRPs are developed based
on experience and successful programs.
For proper validation, these PRPs should be developed, implemented and
shown to be successful for specific manufacturing sites prior to the manufac-
ture of food for the market. ISO 22000 requires that PRPs be continually veri-
fied for effectiveness. One of the outputs of the process becomes the input for
updating the FSMS.
Table 1: PRPs listed in ISO 22002-1
• Construction and layout of buildings
• Layout of premises and workforce
• Utilities: air, water, energy
• Waste disposal
• Equipment suitability, cleaning and
• Management of purchased materials
• Measures for prevention of cross-
• Cleaning and sanitizing
• Pest control
• Product recall procedure
• Product information/consumer
• Food defense, biovigilance and
that food safety is not compromised. If a
section of an FSMS is being excluded,
then there will be a change in the context or assumptions for the FSMS.
A documented hazard that would ex-
clude a section of an FSMS standard
should include the following sections:
• Scope that describes the areas ad-
dressed by the hazard analysis. In ad-
dition, the scope should identify the
reason for the exclusion.
• Describe the context or environment
for ensuring food safety. Most exclusions will change the context on a site
or part of the site. In addition, if the
exclusion is in one part of the site,
then there should be a description
why this exclusion will not affect the
environment for ensuring food safety
in other parts of the site where the exclusion does not apply. This would
include a description of how the
product would be protected.
• Categorize the severity of the hazard
and the likelihood of occurrence. If
the organization does not feel there is
a change in the likelihood of occurrence, the rationale for the decision
needs to be described.
• Any description of best practices or
validation studies to support the
Exclusions to requirements of FSMS
standards can be obtained, but a proper
and detailed risk analysis must be conducted prior to implemention. n
CAC. 2008. CAC/GL 69 2008 Guideline for the
validation of food safety control measures.
Geneva: Codex Alimentarius Commission.
CAC. 2009. Food hygiene — Basic texts, 4th
ed. Geneva: Codex Alimentarius Commission.