Food Safety Magazine, October/November 2011

“...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-
ures or what are the alternative
control measures?
How robust are the existing control
measures?
How effective are the control
measures?
Are there any concerns?
What is the reasoning for the
proposed policy?
What are the current best industry
practices? Are there multiple best
practices?
Is there any chance for food safety to
be compromised?
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

Validation, verification and monitoring are three terms that many food safety practitioners do not fully understand. ISO 22000 defines these activities in the following manner:

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 process.

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
maintenance
• Management of purchased materials
• Measures for prevention of cross-
contamination
• Cleaning and sanitizing
• Pest control
facilities
• Rework
• Product recall procedure
• Warehousing
• Product information/consumer
awareness
• Food defense, biovigilance and
bioterrorism

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.