HACCP master 31.03.10_HACCP2010.

qxd 07/04/2010 14:29 Page 67

Published on 06 May 2010 on https://pubs.rsc.org | doi:10.1039/9781849732086-00067

9. PRINCIPLe 6 – eSTABLISH VeRIFICATIoN

PRoCeDUReS

9.1 Introduction
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There are two aspects to verification of a HACCP study:

1. Validation: is the system capable of making safe food; is the product

safe?
2. Verification: is the system being run as planned and documented; is the
product consistent?

Analytical testing, data collection and auditing are some of the methods
commonly used to answer these questions. Verification is not carried out in
‘real time’. Verification can also be carried out on suppliers. Verification
should be a regular, scheduled event.

9.2 Validation – When and How?

Validation is ensuring that the various parts of the HACCP plan actually
work, and achieve the desired result. Some examples of validation are given
below. Additionally, when the team has completed the first five principles of
the study, the whole study should be reviewed, to ensure that all the controls
for all the relevant hazards have been identified, that the critical and target
limits are correct, and that no hazards have been omitted. It is useful to call
on an expert from outside the HACCP team to carry out this validation.
One of the confusing aspects of validation is that it is included as part of
verification, but this is an activity that is carried out much later, when the
HACCP system is running. Another difference is that validation is usually

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carried out by members of the HACCP team - production, technical or

safety, but verification must be independent, as we will see later.
Another variance is that validation is carried out as a ‘one off’, until
Published on 06 May 2010 on https://pubs.rsc.org | doi:10.1039/9781849732086-00067

changes to the system occur, whereas verification is carried out regularly.

As with all parts of HACCP, records must be kept of these investigations
and activities. Validation will require reviewing if and when changes are
made to the process or product.
You may not have the experience to validate some aspects of your
process; in this case, you can use outside help from the manufacturer of the
equipment concerned, or a trade body or research association, or a
consultant who has worked in the product and process area. As ever,
documentation of the validation process is vital. Statistics should be used
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where appropriate to determine if the process is capable of working.

9.2.1 Some examples of validation

1. A step in the process is to cook a product at 120 ºC for 15 minutes, with

a critical limit that the core temperature must reach 75 ºC for five
minutes. The monitoring procedure is to check the temperature of the
oven. However, to validate the control measure the product is to be
probed at its core, to check that the core temperature does reach 75 ºC
for five minutes.
2. On an automated control continuous pasteuriser the minimum
temperature required is 72 ºC. Validation would involve carrying out an
investigation to confirm that the temperature of the product in the
pasteuriser does reach the temperature indicated by the probe and sensor
on the equipment.
3. The pH of the product is intended to control the growth of a particular
organism. The process is validated by laboratory testing, to ensure
absence of the organism in the finished product before it goes on sale.

As noted in the section on critical limits, it is a little more complex than

that, however, as the oven also needs validating under varying loads, unless
this has been carried out already. Variability in product that could affect the
cook will also require investigating.
Validation usually requires two elements: validation of the process to
ensure that the required critical limit can be achieved, and validation of the
target, to ensure that the process is safe at this point.

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Once all of the CCP critical limits have been validated, the process can
be implemented.
Published on 06 May 2010 on https://pubs.rsc.org | doi:10.1039/9781849732086-00067

Comment:
Validation is a complex process that
must be carried out carefully and
thoroughly to ensure applicability of
critical limits under all likely variations
in the process.
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9.3 Verification

According to Codex, verification is “the application of methods, procedures,

tests and other evaluations, in addition to monitoring, to confirm compliance
with the HACCP plan”.
Verification should be scheduled on a regular basis. Verification includes
random sampling and analysis, including microbiological testing. Although
microbiological analysis is generally too slow for monitoring purposes, it
can be of great value in verification, since many of the identified hazards are
likely to be microbiological.
In addition, reviews of HACCP records are important for verification
purposes. These should confirm that CCPs are under control, and should
indicate the nature of any deviations and the actions that were taken in each
case. It may also be useful to review customer returns and complaints
regularly.

9.3.1 Verification procedures

Audits must be executed by people who were not part of the HACCP team.
They can be carried out by suitably qualified members of staff from other
departments, other HACCP teams in a large company, or an external
consultant. If the company holds accreditation under a manufacturing
standard that includes implementation of HACCP, third party audits carried
out as part of the maintenance of this standard will provide a valuable
contribution to the verification of the HACCP system, as will customer
audits.

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Audit Programme
Published on 06 May 2010 on https://pubs.rsc.org | doi:10.1039/9781849732086-00067

Pre-audit document review

Audit opening meeting

Verify process flow diagram on-site

On-site document review:

HACCP control chart
Internal audit report
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CCP monitor records

HACCP meeting minutes
Training records
Process control charts

Verification of HACCP control chart

Closing meeting

Audit report

Audit follow-up

Fig. 9.1. The Audit Process (Adapted from Mortimore and Wallace, 1998)

Two main procedures used for verification are auditing and product testing.
Internal vs external audits: external audits are carried out to ensure
compliance to a recognised standard: ISO 9001-2000, ISO 22000, BRC
Global Food Issue 5. Internal audits are carried out for company verification,
to maintain readiness for a third party audit, and to comply with a third party
audit scheme.

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Comment:
Independence of auditing is one of the
Published on 06 May 2010 on https://pubs.rsc.org | doi:10.1039/9781849732086-00067

biggest problems within HACCP. For

external audits, the independence of the
auditor is easy to establish; the problem
arises for internal audits.
For a system audit, using members of
the finance department, for example, is
a suitable route and should ensure
impartiality since they are used to
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examining paperwork for compliance.

For a technical or hygiene audit, using
staff from other departments is suitable.
In the latter cases, audit staff must
understand the process or the principles
that they are auditing.

What is audited?

1. Raw material records

2. Production records - thermal logs of key processes, chillers, freezers
3. Process deviation records and actions taken
4. CCP log sheets
5. Finished product test results
6. Process control charts
7. HACCP team meeting records
8. HACCP review records
9. Customer complaints and actions taken
10. Previous Internal Audit reports, non-compliances and actions
completed

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11. Glass register

12. Pest control records
Published on 06 May 2010 on https://pubs.rsc.org | doi:10.1039/9781849732086-00067

13. Hygiene audits

14. Training register/log

The frequency of audits will depend upon the complexity of the process,
severity of hazards and the confidence of the company through historical
data. A relatively new company or one producing a novel product for which
they have no prior knowledge may review records more frequently than a
more established one or a company producing low risk products, for
example dried foods other than infant formula or other food for special
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applications.

Records can be subjected to trend

analysis, either simple graphical, or
statistically applied.

Product testing can be both compositional and microbiological, and is

often an excellent verification that the HACCP system works. Using product
testing is rarely useful for “positive release” of product. Large stocks must
be stored whilst the tests are completed, and the relatively high level of
sampling required for sensibly confident positive release decisions can be
prohibitively expensive. In any case, it can still be difficult to guarantee
absolute food safety after microbiological testing.

9.4 Summary

9.4.1 HACCP Review

If the HACCP study has been carried out properly it will be working shortly
after implementation, but it is important that procedures are established to
continue the verification. The HACCP team needs to decide what events are
to trigger a review of part or all of the HACCP system. The review can be
in the form of an audit, and/or possibly revalidation of a particular control.
The following are examples of events that should trigger a review:

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• Repair of equipment following major breakdown

• Change of supplier or origin of one or more ingredients
Published on 06 May 2010 on https://pubs.rsc.org | doi:10.1039/9781849732086-00067

• Recipe modification
• Adverse comment from Enforcement Officer or customer audit
• Unexpected level of a particular type of consumer complaint
• Process modification
• Emergence of a hazard not considered in the original HACCP
• New information about an existing hazard

Regardless of the events listed above, the HACCP plan should be

reviewed annually.
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Scheduled vs Triggered Audit?

The annual audit is an example of a
scheduled audit, whereas the audit or
review after a change listed above is a
triggered audit. Both are vital within
HACCP. One of the purposes of the
scheduled audit is to capture any
changes that may have slipped through
during the year.

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