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Chapter 4.2 HACCP Based Procedures

The document outlines the Manual for Official Controls, focusing on HACCP-based procedures, including legislation, common issues in auditing, and implementation requirements. It emphasizes the importance of flexibility in applying HACCP principles based on the nature and size of food businesses. Additionally, it provides guidance for food business operators (FBOs) and official veterinarians (OVs) on maintaining compliance with HACCP regulations.

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0% found this document useful (0 votes)
11 views28 pages

Chapter 4.2 HACCP Based Procedures

The document outlines the Manual for Official Controls, focusing on HACCP-based procedures, including legislation, common issues in auditing, and implementation requirements. It emphasizes the importance of flexibility in applying HACCP principles based on the nature and size of food businesses. Additionally, it provides guidance for food business operators (FBOs) and official veterinarians (OVs) on maintaining compliance with HACCP regulations.

Uploaded by

Saraturituri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 28

Manual for Official Controls | Amendment 84

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Chapter 4.2 HACCP Based


Procedures

Section 1 Introduction

Section 2 Common issues for HACCP auditing

Section 3 Audit and enforcement

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1. Introduction

1.1 Legislation

1.2 Characteristics of HACCP based procedures

1.1 Legislation

1.1.1 HACCP legislative framework


The following table summarises the different pieces of legislation that cover FBO
and OV responsibilities in relation to HACCP based procedures.

Regulation Issue Who is Other


responsible? documents
Reg (EC) Ch II, Put in place, implement and • Commission
852/2004 Article 5 maintain a permanent Guidance
procedure based on HACCP • MIG
principles FBO
• Food Safety
Management
Diary for Meat
Producers
Annex II, Train staff responsible for • Commission
the development and Guidance
Ch XII maintenance of HACCP
FBO • MIG
based procedures in the
application of HACCP
principles

Reg (EC) Annex II, List of HACCP based


• Commission
853/2004 Section II objectives for incoming
FBO Guidance
animals accepted for
slaughter • MIG

Reg (EC) Ch II, Audit and verification that • MOC


OV
854/2004 Article 4 FBOs apply HACCP • MIG

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principles continuously and • Food Safety
properly Management
Diary for Meat
Producers

1.1.2 (EC) 852/2004 evidence


The FBO shall provide the OV with evidence of their compliance with the HACCP
legal requirements, taking into account the nature and size of the business, and
ensure that any documents describing the procedures are up to date at all times.

The instructions in this chapter reflect the minimum requirements expected to


consider an FBO plan of HACCP-based procedures adequate and in compliance
with the Regulations.

Regulation: (EC) 852/2004, Chapter II, Article 5.

1.1.3 (EC) 854/2004 OV verification of HACCP based procedures


The OV is required to conduct audits to verify that food business operators apply
HACCP based procedures continuously and properly to make sure, in particular,
that:

• procedures guarantee that the requirements for incoming animals are met
• meat complies with the microbiological criteria
• meat complies with the community legislation on residues, contaminants
and prohibited substances
• meat does not contain physical hazards, such as foreign bodies
Regulation: (EC) 854/2004, Chapter II, Article 4, 5.

1.1.4 Key reference documents


The MIG contains information for FBOs on the application of HACCP based
principles to comply with the legal requirements as well as advice. It takes
account of the Commission’s guidance on flexibility and includes generic HACCP
plan material. It should be read by OV’s advising on or auditing the
application of HACCP principles.

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The European Commission has produced a guidance document for the
implementation of procedures based on HACCP principles and to facilitate the
implementation of HACCP principles in certain food businesses.

Reference: MOC, Volume 2 Legislation for additional information.

‘The Diary’ has been produced by the FSA for smaller operators and can be found
within the MOC titled as ‘Food Safety Management Diary’.

The Diary is specifically designed to facilitate FBOs to keep records relating to the
hygienic operation of their businesses. It also includes draft documentation on
prerequisites and HACCP.

The use of the Diary by FBOs is voluntary.

Reference: See the topic 2.10 on ‘Principle 7: documentation’ in part 2 for


additional information.

1.2 Characteristics of HACCP based procedures

1.2.1 Purpose
HACCP principles are a tool for FBOs to use to control hazards that may occur in
food.

HACCP is a set of 7 principles used to assess hazards and establish control


systems that focus on prevention of problems rather than relying solely on end-
product testing.

1.2.2 Implementation requirements


The successful application of HACCP based procedures requires the following:

• the FBO must already have implemented the hygiene controls that are
required by legislation (prerequisites / good hygiene practice)
• requires the full commitment of management and the involvement of the
work force

1.2.3 ‘Traditional’ HACCP vs. HACCP based procedures


‘Traditional’, ‘classic’ or ‘technical’ HACCP is not the same as ‘HACCP based
procedures’.

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Traditional HACCP evolved from spacecraft manufacture to guarantee the safety
of astronauts’ food. It remains appropriate for industrial production of processed
foodstuffs involving for example, sterilisation or pasteurisation steps.

It is however acknowledged in (EC) 852/2004 and particularly in the Commission’s


guidance on HACCP that such a technical approach may not be appropriate for all
types and sizes of food businesses. In the case of meat plants, for example, it
can be sufficient to apply the principles in a more flexible way following guides to
practice.

1.2.4 ‘Flexibility’: Nature and size of the operations


Flexibility regarding the application of HACCP principles may be applied, taking
into account:

• the nature of the operations


• the size of the business
Flexibility taking Comments
into account
Nature of the In businesses handling food with no significant food safety
operations hazards (for example, greengrocers) a hazard analysis
confirming that is the case can be sufficient.

In businesses handling many foods (for example, restaurants)


a simplified approach using a diary can be sufficient.

In businesses involving simple processing (for example,


slaughterhouses and cutting plants) a generic plan with a diary
for record keeping can be sufficient as long as they are
adapted to reflect company conditions.

In food manufacturing businesses, particularly with procedures


that will eliminate hazards (for example, canning plants) full
technical HACCP is more appropriate.

OV auditors should consider whether the HACCP based


procedures are appropriate for the type of business.

Size of the business The size of business and resources available will have a
/ documentation bearing on the complexity of the HACCP based system;
however a simple, easily managed system can achieve the
safe production of food as well as a more complex system.

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A traditional HACCP system relies heavily on recording that all
the procedures are being followed correctly, probably by the
Quality Control, Quality Assurance or HACCP team.

Small and medium sized businesses rarely require the same


level of documentation. They may choose to record when
things go wrong, called ‘exception reporting’.

Reference: See the topic 2.10 on ‘Principle 7: Documentation’


in Part 2 for additional information.

OV auditors should note that there is no value in FBO


documentation being disproportionate to the level of risk and
the recording of HACCP based monitoring procedures being a
burden to small-medium businesses.

1.2.5 Flexible application of HACCP principles


FBO application of HACCP principles should meet the following criteria:

• identify the main hazards associated with the type of product produced and
the operations carried out
flexibility: hazards - generic descriptions of hazards may be sufficient
• identify those Critical Control Points (CCPs) / Control Points (CPs)
necessary to control those hazards; the FBO may choose to have in the
plan only CPs which are legal requirements
flexibility: CCPs - generic guidance may include pre-determined CCPs
in the preparation, manufacturing and processing of food
• establish critical (or legal) limits against which to monitor the effectiveness
of control measures at CCPs / CPs
flexibility: critical limits - it is not always necessary to fix a numerical value,
especially where monitoring procedures are based on visual observation
(for example, the faecal contamination of carcases in a slaughterhouse)
• monitor CCPs / CPs
flexibility: monitoring - may be a simple procedure, for example, a visual
observation to monitor whether the correct de-hiding procedure is being
applied during slaughter where this part of the slaughter process has been
identified as a CCP for preventing carcase contamination

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• take the necessary corrective actions based on the results of the
monitoring activities
• record the observations and corrective actions taken; the requirement of
retaining documents needs to be flexible in order to avoid undue burdens
for small / medium businesses
flexibility: recording – in the case of visual monitoring procedures it can be
acceptable to record results only when there is a problem and the
corrective action that has been taken; that is, ‘exception reporting’; a diary
can be a suitable method of record keeping

• verify the HACCP-based procedures


flexibility: verification – checking all aspects of the HACCP plan can be
spread throughout the year so that all aspects are verified at least once a
year to meet the requirement for ‘regular’ verification
Reference: See the MIG chapter 9 on ‘HACCP’ for additional information.

1.2.6 Review of HACCP based procedures


The HACCP procedures should be reviewed and necessary changes made by the
FBO when any modification is made in the product, process or any step.

1.2.7 OV role
OV’s, through auditing, need to determine the level of FBO compliance with
HACCP principles always taking into consideration the possibility of implementing
simplified HACCP based procedures particularly in small / medium sized
businesses.

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2. Common Issues of HACCP Auditing

2.1 Introduction

2.2 Training

2.3 Implementation and maintaining HACCP based procedures

2.4 Principle 1: Hazard analysis

2.5 Principle 2: Determine critical control points (CCPs) / control


points (CPs)

2.6 Principle 3: Establish critical limits (CLs) / legal limits (LLs)

2.7 Principle 4: Monitoring of CCPs / CPs

2.8 Principle 5: Corrective action procedures

2.9 Principle 6: Validation, verification and review

2.10 Principle 7: Documentation

2.1 Introduction
This section covers common issues for OV’s to consider when auditing a food
safety management system based on HACCP principles in compliance with the
regulation.

2.2 Training

2.2.1 Staff responsible for HACCP based procedures


Those responsible for the development and maintenance of HACCP-based
procedures have received adequate training in the application of HACCP
principles. Regulation: (EC) 852/2004, Annex II, Chapter XII, 2.

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2.2.2 Training: common issues
The following table contains examples of common issues that the OV could find
when auditing HACCP based procedures and guidance on how the OV should
make the assessment to determine FBO compliance:

Common Issues OV advice / guidance


No member of staff with Formal training is not a legal requirement; the FBO however,
formal training should show that they have received ‘supervision, instruction and /
or training’.
This can be achieved in a number of ways including (list not
exhaustive):
• one to one instruction
• day courses
• in house courses
• distance learning courses.
These may or may not be accredited courses; however, there
should be evidence of training. Examples include: certificates,
completed test papers, questionnaires, personal assessment
papers and individual training records showing instruction or
training received.
Reference: See the MIG chapter 9 on ‘HACCP’ and the MOC
volume 2 on ‘Commission guidance’ for additional information.
The FBO believes they If external advisers / consultants are used, they should do so as
do not require any part of a HACCP team, providing instruction and guidance rather
training at all as the than working independently and writing the system for the FBO. It
HACCP based system may mean that the FBO is unable to answer questions or make
has been written by an amendments without reference to the adviser. This raises the
external adviser / question of whether the staff can be maintaining their HACCP-
consultant based procedures and has adequate training to do so.

Instruction given by the external adviser / consultant to the FBO


should be recorded on individual training records.

Primary responsibility for food safety rests with the FBO, so


ownership of the food safety system should be that of the FBO.

Regulation: (EC) 852/2004, Chapter I, Article 1, 1(a).

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2.3 Implementation and maintaining of HACCP based procedures

2.3.1 HACCP implementation and maintaining


FBOs shall put in place, implement and maintain a permanent procedure or
procedures based on the HACCP principles taking into account the nature and
size of the business.

Regulation: See the MOC volume 2 legislation on (EC) 852/2004, Recital 15 and
Article 5, 1 and the EC Commission Guidance document on implementation of
procedure based on the HACCP principles.

2.4 Principle 1: Hazard analysis

2.4.1 Hazard identification


The FBO is responsible for identifying any significant hazards that must be
prevented, eliminated or reduced to acceptable levels.

Regulation: (EC) 852/2004 Article 5, 2(a).

2.4.2 Hazard identification: common issues


The following table contains examples of common issues that the OV could find
when auditing HACCP based procedures and guidance on how the OV should
make the assessment to determine FBO compliance:

Common Issues OV advice / guidance


The product description Flexibility as to what is included should relate to the technical
does not include nature of the production process. For example, a meat plant
technical information producing a meat preparation and / or meat product is likely to
require a greater amount of data such as microbiological criteria,
moisture content. than a meat plant that simply cuts and packs a
raw product. Large meat plants that have qualified technical
teams / advisers may have the necessary skills to write a very
detailed and validated technical description of the process; this
may not be the case in small – medium businesses with fewer
resources.
Flow diagram does not A flow diagram (CODEX HACCP guideline) used in a traditional
show all steps in a HACCP system will describe all inputs into the food business (such
process as packaging and ingredients), the different stages of process and

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how different foods are stored. Generic systems based on
HACCP principles may use a ‘simplified’ flow diagram; this is an
identification (rather than description) of each process step.
Certain process steps may be grouped together when the risks are
the same, for example, removing bones from a carcase and cutting
the boneless meat into cubes. Although these are two different
procedures, the hazards will be the same, therefore the process
step may be written and simplified as follows:
• remove bone and prepare meat.
Note: It is essential that flow diagrams accurately reflect the whole
process (are validated), so that the remaining HACCP principles
are correctly considered and described.
Hazards identified do A technical HACCP study completed by a multi-disciplinary team
not specify individual will be based on extensive research to ensure that all potential
contaminants such as hazards, biological, physical, chemical and allergenic are identified
salmonella, rust, for example, the effect of competition from spoilage bacteria on the
chemicals, peanuts survival of food-borne pathogens.
This level of detail is unlikely to be achieved by small – medium
businesses with limited resources, who may address individual
hazards by groups, for example,
Biological contamination:
The naming of each type of pathogenic bacteria that may be a
contamination / cross-contamination hazard would be appropriate
for larger plants but not for businesses following a generic plan.
At the chilling step a generic hazard will be ‘Growth of bacteria due
to inadequate temperature control’. It is unnecessary for the FBO
to have an in-depth understanding of microbiology.
It is sufficient that the plan recognises the dangers of poor
temperature control in relationship to bacterial growth.
Importantly, FBOs should recognise the need to minimise the level
of micro-organisms at each stage of the supply chain as there is a
risk of cross contamination of ready-to-eat products by raw meat
before it is itself cooked.
Hazards identified do Physical contamination:
not specify individual Individual hazards, such as parts from machinery, contamination
hazards from building fabric, may be combined and identified as
‘contamination due to foreign objects’.

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such as salmonella, Chemical contamination:
rust, chemicals, The plan may not identify a significant chemical hazard. Cleaning
peanuts chemical hazards should be controlled by the application of
hygiene controls, such as cleaning procedures (adhering to a
Cleaning Schedules) and a list of chemical used (Cleaning
Record).
In respect of allergenic reactions, few people display allergic
reactions to meat, so in raw meat slaughter / processing it is
unlikely to be a significant hazard, however this risk would need to
be considered when processing a meat preparation or product,
which may contain relevant products such as soya, egg, sesame.
Reference: See the MIG chapter 5 on ‘Cleaning’ for additional
information.
OV’s should note the above differences applying flexibility.
Inaccurate control ‘Control measures’ are necessary to control significant hazards
measures identified from contaminating a food, for example, the chilling of meat down
to a desired temperature and the implementation of maintenance
procedures.

The plan of HACCP-based procedures may not distinguish control


measures from monitoring procedures and may include visual
inspections / observations as control measures.

Visual inspection should be regarded as a monitoring procedure,


however, although not technically correct, the inclusion of
monitoring as a control measure does not have an adverse effect
on the safety of food.

2.5 Principle 2: Determine critical control points (CCPs) / control


points (CPs)

2.5.1 CCP / CP identification


Identifying the Critical Control Points (CCPs) (or Control Points (CPs)) at the step
or steps at which control is essential to prevent or eliminate a hazard or reduce it
to acceptable levels.

Regulation: (EC) 852/2004 Article 5, 2(b).

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2.5.2 Difference between CCP and CP
In the processing of raw meat it may not be possible to prevent or eliminate
hazards and reduction steps may not be measurable in the same way as, for
example, when food is canned.

Therefore, FBOs may consider that for their product and / or operations there are
no ‘traditional’ CCPs. There are process steps, however, where controls are
necessary to meet legal objectives. If these process steps are not chosen as
CCPs they should nevertheless be included in the plan of HACCP-based
procedures as Control Points (CPs) required by legislation and which are to be
monitored and corrective actions taken.

Examples of those control points are:

• acceptance of animals for slaughter, to ensure animals are identified, clean


and healthy
• evisceration and dressing, to ensure absence of visible contamination
• SRM controls, to ensure absence and proper disposal of SRM
• temperature controls to limit growth of micro-organisms
• receipt / pre-cut inspection of raw meat, to ensure raw materials are free
from contamination
Reference: See the MIG chapter 9 on ‘HACCP’ for additional information.

2.5.3 CCPs / CPs common issues


The following table contains examples of common issues that the OV could find
when auditing HACCP based procedures and guidance on how the OV should
make the assessment to determine FBO compliance:

Common Issues OV advice / guidance


CCPs either not present In certain food businesses there will be steps in the process that
or not identified are critical to the safe production of food, for example, cooking a
correctly raw food to a specified core temperature. A decision tree may be
used to determine CCPs.
On the other hand, a small-medium slaughterhouse or cutting plant
handling raw meat may follow a generic approach where CCPs /
CPs are pre-determined and so a decision tree may not be
needed.

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2.6 Principle 3: Establish critical limits (CLs) / legal limits (LLs)

2.6.1 Establishing CLs/ LLs


Establishing critical limits (CLs) (or legal limits (LLs)) at CCPs (or CPs) which
separate acceptability from unacceptability for the prevention, elimination or
reduction of identified hazards.

Regulation: (EC) 852/2004 Article 5, 2(c).

Limits do not need to be a fixed numerical value that requires measurement.


Limits can be monitored through visual observation, for example, faecal
contamination of carcases.

2.6.2 Difference between CLs and LLs


CLs separate acceptability from unacceptability or safe from unsafe food at CCPs.
CLs must be at least as strict as legal requirements that apply at that process step
for example, temperatures for raw meat.

LLs are values set out in the legislation to be used where FBOs have decided to
have CPs (instead of CCPs) which are legal requirements.

2.6.3 CLs / LLs – common issues


The following table contains examples of common issues that the OV could find
when auditing HACCP based procedures and guidance on how the OV should
make the assessment to determine FBO compliance:

Common Issues OV advice / guidance


Hygiene controls set as In a technical HACCP system CLs may include:
Critical Limits • values of temperature, time
• maximum residue limits
• maximum levels (of contaminants)
• microbiological criteria
• levels of chlorine
Hygiene controls set as In some cases the plan of HACCP-based procedures may not
Critical Limits, distinguish critical limits from the application of hygiene controls for

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example, cleaning procedures, maintenance procedures and pest
control.
Where FBOs have decided to have CPs (instead of CCPs) which
are legal requirements, the LLs may include strict adherence to a
hygiene control. This does not have an adverse effect on the
safety of food.

2.7 Principle 4: Monitoring of CCPs / CPs

2.7.1 Monitoring procedures


Establishing and implementing effective monitoring procedures at CCPs (or CPs).

Regulation: (EC) 852/2004 Article 5, 2(d).

2.7.2 Monitoring procedures: common issues


The following table contains examples of common issues that the OV could find
when auditing HACCP based procedures and guidance on how the OV should
make the assessment to determine FBO compliance:

Common Issues OV advice / guidance


Monitoring procedures Monitoring procedures are an important part of a HACCP based
not recorded system, in some cases monitoring may not be recorded, or
recorded just to pass an audit, and have no bearing on what is
actually happening in the meat plant.

Reference: See topic 2.10 on ‘Principle 7: Documentation’ in part


2.

Plan not a true The monitoring procedures described in the plan should reflect
reflection of reality those actually carried out.

Disproportionate Extensive record keeping may prove to be burdensome for an


monitoring procedures FBO to maintain (for instance when documentation / records have
been produced by a third party (consultant) who does not
understand the food business operations, for example,

• twice daily recordings carried out by staff of the temperature


of all knife sterilisers using a probe thermometer; resulting in
hundreds of manual checks per week

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• daily manual recordings of the air temperature of a chiller
using a probe thermometer that is already monitored
automatically and linked to a warning alarm.
Monitoring is ‘the act of conducting a planned sequence of
observations or measurements of control parameters to assess
whether a CCP (or CP) is under control’ therefore monitoring may
or may not include written records of any checks carried out.

Information recorded will be dependent on the risk of the


operations; that is, the type of food and size of the business.

Documentation should not cause an unnecessary burden to small


– medium businesses.

The FBO may choose to record by exception (using a diary such


as the
https://foodgov.sharepoint.com/operations/Documents/MOC/fsm_di
ary.pdf#search=food%20safety%20diary in which case the amount
and type of records will not be the same as those used in a
traditional HACCP system.

The Diary may also be the preferred choice of the FBO to record
occasional checks, for example, product temperatures taken on a
daily basis, rather than recording on separate sheets of paper.

Reference: See the topic 2.10 on ‘Principle 7: documentation’ in


part 2 for additional information.

2.8 Principle 5: Corrective action procedures

2.8.1 Establishing corrective actions


Establishing corrective actions when monitoring procedures at CCPs (or CPs).

Regulation: (EC) 852/2004 Article 5, 2(e).

2.8.2 Corrective actions: common issues


The following table contains examples of common issues that the OV could find
when auditing HACCP based procedures and guidance on how the OV should
make the assessment to determine FBO compliance:

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Common Issues OV advice / guidance


Plan not a true The corrective action procedures described in the plan should
reflection of reality reflect those actually carried out.
Corrective actions not Corrective actions are an important part of a plan of HACCP-based
recorded procedures to bring production back under control. In some cases
the actions taken may not be recorded as the FBO does not want
to admit to failures. The impression given is that the FBOs never
have any problems with their hygiene control procedures.
In fact, the record of corrective actions shows that the plan based
on HACCP principles is a ‘healthy’ plan that works effectively.
Corrective actions should ensure that the risk to consumers are
eliminated, prevented or reduced for example, trimming of faecal
contamination.
Corrective actions not Problems always occur and records should be made when they
recorded do.
These records are important for the FBO to enable verification of
the HACCP based system.
Examples on how to record corrective actions may include:
a comment made on a cleaning check-sheet when problems have
been identified during cleaning by staff entering the problem and
the action taken by use of a diary such as the
https://foodgov.sharepoint.com/operations/Documents/MOC/fsm_d
iary.pdf#search=food%20safety%20diary

2.9 Principle 6: Validation, verification and review

2.9.1 Validation
The FBO is required to validate the plan before implementation and after any
amendments or reviews.

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2.9.2 Verification
Establishing procedures which shall be carried out regularly to verify that what is
written in the HACCP plan is actually being carried out in the work place and is
working effectively.

Regulation: (EC) 852/2004 Article 5, 2(f).

2.9.3 Review
When any modification is made in the product process, or any step, the food
business operators shall carry out a review of the HACCP based procedure
plan(s) to ensure that the plan(s) and associated documentation are up to date.

Regulation: (EC) 852/2004 Article 5, 2.

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2.9.4 Validation / Verification / Review: common issues
The following table contains examples of common issues that the OV could find
when auditing HACCP based procedures and guidance on how the OV should
make the assessment to determine FBO compliance:

Common Issues OV advice / guidance


Plan not a true reflection The validation, verification and review procedures described in the
of reality plan should reflect those actually carried out.
No records of Plans based on HACCP principles allow for flexibility in the
Verification / Validation / application. The FBO may combine validation (of the HACCP
Review of the HACCP plan), verification and review (of the system); as it may be difficult
plan(s) for the FBO to distinguish between them.
Absence of separate validation / verification / review checks does
not necessarily mean these have not been carried out.
Verification of these procedures may be completed by an internal
audit / or external audit(s) carried out by the competent authority or
third party auditors.
Examples of separate validation, verification and HACCP plan
review forms are provided in the
https://foodgov.sharepoint.com/operations/Documents/MOC/fsm_di
ary.pdf#search=food%20safety%20diary which the FBO may
choose to use.
If the Diary is used the 4-weekly reviews also accomplish
verification of the FBOs hygiene controls.

2.9.5 Microbiology
Microbiological testing is another way of verification of HACCP based procedures.

Microbiological requirements are contained in Regulation (EC) 2073/2005.

Surface microbiological testing is not a legal requirement but the FBO may decide
to do so as a way of verification of their cleaning procedures.

Reference: See part 3 section 3 on ‘Verification of microbiological criteria’ for


additional information.

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2.10 Principle 7: Documentation

2.10.1 Establish documents and records


Establishing documents and records commensurate with the nature and size of
the business to demonstrate the effective application of the measures outlined in
subparagraphs (a) to (f):

a. identifying hazards
b. identifying CCPs (or CPs)
c. establishing CL (or LL) at CCPs (or CPs)
d. establishing and implementing monitoring procedures
e. establishing corrective actions
f. establishing verification procedures (including validation and review)
Regulation: (EC) 852/2004 Article 5, 2(g)

2.10.2 Types of documents and records


Three types of paperwork are necessary:

• HACCP plan(s) documenting application of HACCP principles (may be a


generic plan – amended to reflect the company procedures including
prerequisites that are control measures)
• company’s HACCP-based procedures, policies, staff instructions (should
include prerequisites as control measures)
• records of monitoring, corrective action, verification and review (the Food
Safety Management Diary may be used)

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2.10.3 Documentation: common issues
Common Issues OV advice / guidance
Plan not a true reflection The documentation referred to in the plan of HACCP-based
of reality procedures should reflect those actually maintained by the FBO.
Disproportionate Documentation, especially if it is produced by an external adviser,
documentation may be disproportionate to the size, type of business and type of
food produced. It may be too technical for the FBO or plant staff to
understand or follow; it may duplicate existing records or seek to
introduce a far more complex system of recording than is
appropriate.
In these cases it may be appropriate to encourage the FBO to
consult with their adviser / consultant and work together to produce
a workable, more easily managed HACCP based system,
reminding the FBO that the HACCP based system is their control
system and they should retain ownership.

2.10.4 Food safety management diary for meat producers (‘The Diary’)
The use of the FSA’s Food Safety Management Diary for Meat Producers (the
‘Diary’) is an acceptable method of record keeping.

When using the diary, the FBO or other responsible person should sign the Diary
every day to say:

• opening, operational and closing checks have been carried out


• hygienic production has been followed
These are not just a tick in a box, if these have been ticked the workplace must
accurately reflect the check carried out for example, areas, equipment are / is
clean, knife sterilisers are working correctly.

The daily Diary pages are not intended to replace all existing documentation.
They will need to be supported by additional record forms and procedures / staff
instructions such as:

• individual staff training records


• cleaning schedules
• maintenance plans

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The Diary provides examples of such documents that FBOs may adapt for their
own use. FBOs may choose to keep such prerequisite records in the Diary
binder.

The use of the Diary by FBOs is voluntary. It will not be appropriate in businesses
that already have good existing records, and may not be entirely sufficient where,
for example, the business is accredited to a Quality Assurance scheme or
customers require more extensive documentation.

Reference: An electronic version of the Diary can be found at:

https://foodgov.sharepoint.com/operations/Documents/MOC/fsm_diary.pdf#search
=food%20safety%20diary

2.10.5 Exception recording


FBOs may choose to do exception recording, only to make record when a
problem or something out of the ordinary is identified and the corrective actions to
regain control. This applies particularly to checks that are more or less continuous
for example, visual monitoring of each carcase, or where separate checklists are
kept for example, cleaning checks.

Examples of exceptional recording:

• record when temperatures exceed the critical / legal limit and the action
taken to regain control instead of having to tick / cross a separate list
• instead of making ticks and crosses in a cleaning checklist every day, an
alternative could be recording only when cleaning problems are identified
including the corrective action
• trimming contamination from a carcase
• recording problems that occur during a process for example, gut spillage
during evisceration
• action taken when there are signs of pest infestation
• action taken if refrigeration equipment requires repair
• problems with faulty equipment and what was done to put it right
• staff not adhering to pre-requisite or other procedures and what corrective
actions were required for example, supplementary or refresher training,
cleaning of a piece of equipment
• knife sterilisers that are not working at 82°C or above and what corrective
actions were required for example, repair / renew equipment

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FBOs should nevertheless be encouraged to record the results of occasional
checks to demonstrate that their procedures are working effectively, for example,

• periodic checks of knife sterilisers


• chiller temperatures
Problems and corrective actions taken do not show a weak HACCP plan but a
healthy HACCP plan that works effectively.

2.10.6 Management checks


Management checks are an integral part of FBO food safety management to
ensure that prerequisite controls are working effectively.

Four weekly checklists are provided in the Diary to encourage FBOs to undertake
a regular review of all aspects of their hygiene controls. There is space to record
any persistent problems (which may include concerns raised by OV inspections or
audits) or any significant changes that have been made and how they are being
dealt with, including any consequences for their HACCP-plans.

Reference: See the topic 2.9 on ‘Principle 6: validation, verification and review’ in
part 2 for additional information.

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3. Audit and Enforcement

3.1 OV audit of HACCP principles and microbiological testing

3.2 Enforcement: HACCP

3.1 OV audit of HACCP principles and microbiological testing

3.1.1 Audit 9/3 form


OV’s should use the MS Excel audit report form AUD 9/3 to audit FBO compliance
in the application of HACCP based procedures.

Reference: see chapter 9 on ‘Forms’ for the MS Excel audit report form.

When one establishment has several HACCP based procedures plans, the OV
only need to complete one ‘HACCP based procedures’ section of the form AUD
9/3 which will cover the audit findings for all the HACCP based procedures plans
of one establishment.

3.1.2 Confidence in FBO’s food safety management systems AUD 9/3


The results of the audit of the FBO compliance in the application of HACCP based
procedures is one of the main audit components to be used by the OV to
determine the ‘Food safety systems based on HACCP principles’ (confidence in
FBOs food management systems) score in part 2 of the form AUD 9/3.

3.1.3 OV HACCP audit objective


The objective of the OV audit should be to establish whether the FBO can show
that they have implemented and are maintaining a system based on HACCP
based procedures to a reasonable degree.

Note: HACCP based procedures will not work without sufficient / adequate /
appropriate prerequisites (good hygiene practices) being in place (as required by
Regulation (EC) 852/2004 in particular).

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3.1.4 Technical deficiencies
The plan based on HACCP principles may not be technically correct but this does
not make it invalid (or require formal enforcement action) as it may achieve the
main purpose of controlling the main hazard for the production of safe food.

Example:

A flow diagram that does not correctly reflect the operations carried out; however,
there is no risk for public health as the risks have been correctly identified.

Reference: See sub-topic 3.2.1 on ‘OV advisory role’ in part 2 for additional
information.

3.1.5 OV HACCP audit


The OV should determine through Part 2, (HACCP based procedures section) of
the AUD 9/3 the FBO level of compliance as active, broad, weak or poor
compliance.

The text at the foot of the page in each section of the AUD 9/3 describes the
active, broad, weak or poor compliance criteria. The decisions on which criteria
is appropriate is a matter of professional judgment of the OV auditor based on the
guidance provided in this chapter.

3.1.6 OV microbiological testing audit


The OV should verify that the FBO complies with the microbiological sampling
requirements, laid down in (EC) 2073/2005, in accordance with (EC) 882/2004.

OV verification and reporting through part 2 of AUD 9/3 include FBO responsibility
for:

• sampling at the required frequency


• following the sampling rules
• interpretation of the sampling results (do these look manufactured or
unrealistic?)
• identification of patterns and trends in test results
• identification of failures in the processing techniques that should have been
identified and addressed
• corrective action, where necessitated by the results obtained

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• a product recall, where necessitated as a result of unsatisfactory food
safety criteria results
Reference: For additional information see the MIG.

3.2 Enforcement: HACCP

3.2.1 OV advisory role


Where the OV finds that the FBO has HACCP based procedures but there are
deficiencies that do not pose a public health risk, the OV should not serve a formal
notice, but advise, educate and encourage rectification of the HACCP based
procedures.

The FBO may be directed to the MIG for guidance, and in particular the advice on
HACCP training, as well as to the Meat Plant HACCP Manual and the Food
Safety Management Diary sample documents.

Reference: For guidance on HACCP implementation refer to


http://www.food.gov.uk/business-industry/meat/haccpmeatplants

The electronic version of the Diary can be found at

https://foodgov.sharepoint.com/operations/Documents/MOC/fsm_diary.pdf#search
=food%20safety%20diary

The OV advisory role does not extend to personally writing any part of the FBOs
food safety system for example, HACCP plans and monitoring documentation.

3.2.2 Objective evidence


It is essential to gather evidence of legal contraventions for example,

• the slaughter for human consumption of animals whose identity cannot be


reasonably ascertained
• carcases presented with faecal contamination at post mortem inspection,
when these are related to the inadequacy (or non-existence) of the FBOs
HACCP-based food safety management procedures

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3.2.3 Notification to the FBO of deficiencies
If after verbal advice and an advisory letter the FBO has made:

• no effort to implement a food safety management system based on HACCP


based procedures, or
• negligible effort to implement a food safety management system based on
HACCP based procedures, or
• once implemented, the FBO has failed to maintain a system based on
HACCP based procedures
The OV is to serve a Hygiene Improvement Notice (HIN) for each of the HACCP
principles that are not being complied with.

Regulation: (EC) 852/2004, Chapter II, Article 5 and (EC) 853/2004, Annex II,
Section II.

3.2.4 Plant functions


Separate HIN’s are to be served on each of the establishment’s approved
functions, such as slaughtering and cutting. Separate notices avoid:

• having to withdraw an entire notice that has only be partially complied with
• the suspension of entire notices because of appeals over one issue
• the service of more notices on those areas still outstanding

3.2.5 Time scales for compliance with formal notices


The timescale for compliance with the HIN will depend upon the size of the
establishment, the nature and complexity of the operations and the history of
compliance of the FBO. The OV is responsible for making an assessment of the
specific circumstances for the plant to provide a reasonable timescale in line with
the enforcement concordat and risk based procedures (it is proportionate).

3.2.6 Failure to comply with the notice


If the FBO fails to comply with the HIN(s), the OV should recommend prosecution
by completing the Prosecution Report (ENF 11/6).

Reference: See chapter 9 on ‘Forms’.

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The OV must keep a record of the FBOs progress on HACCP implementation
made after a recommendation for prosecution has been made. This will help
identify actions that should have been taken earlier and will help to counter any
mitigating factors that the FBO puts forward if the case goes to court.

3.2.7 OV records of FBO compliance


The OV must keep records in the plant daybook and the audit report form (AUD
9/3) of the advice given to the FBO.

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