Manual Control-Oficial Audit Engl

8/8/2019 Manual Control-Oficial Audit Engl

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MHS Manual for Official ControlsChapter 4: Audit & HACCP Based Procedures

Amendment 28

Chapter Overview i

Audit & HACCP Based Procedures

Chapter Overview

In thischapter

The table below lists the parts in this chapter.

Part 1 Audit

Part 1 - AnnexesAnnex 1 Examples of Completed Risk AssessmentsAnnex 2 Co-located Cold Store Aide Memoire

Part 2 HACCP Based Procedures


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MHS Manual for Official ControlsChapter 4, Part 1:Audit

Amendment 28

Overview i

Audit

Part 1 Overview

In this part The table below lists the sections in this part.

Section SeePage

Section 1 Introduction 1-1Section 2 Legislation 2-1Section 3 FBO Responsibility 3-1Section 4 MHS Role 4-1Section 5 Risk Assessment 5-1

Annexes

Annex 1 Examples of Completed Risk AssessmentsAnnex 2 - Co-located Cold Store Aide Memoire


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Section 1

Introduction 1-1

Section 1 I ntroduction

Section Overview

In thissection

The table below lists the topics in this section.

Topic SeePage

Purpose 1-2Relationship between OV Attendance and AuditFrequency

1-4


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Section 1

Introduction 1-2

Purpose

Relevant

premisesThese audit arrangements apply to all meat establishments

approved in Great Britain and under veterinary control.These are:

red meat/farmed game slaughterhouses,

poultry meat slaughterhouses,

cutting plants (including previous catering butchers)

wild game plants,

minced meat, meat preparations and mechanicallyseparated meat plants co-located with slaughterhousesor cutting plants,

meat product plants co-located with slaughterhouses andcutting plants,

co-located cold stores.

Riskassessmentscheme

The audit risk assessment scheme applies the requirement of(EC) 854/2004 to determine the frequency of audit using therisk criteria set out in that Regulation:

public health risks

animal health risks (where appropriate)

animal welfare risks (where appropriate) type of process carried out

throughput

FBOs record of compliance with food law.

Aim of OVaudits

The twin aims of the OV audits of FBO procedures are toverify compliance with the legal requirements and to ensureadequate FBOs standards in relation to public health andanimal welfare.

The audit sections in the audit report are based on thepriorities set for the MHS that have been agreed between theMHS, FSA and Defra.

Audit findings should provide individual FBOs as well as therelevant competent authority (MHS, FSA and Defra) withinformation on areas for correction or improvement. For theCompetent Authority, this may result in the review of theMOC and/or MIG or the development of new guidance,

procedures and training.

Continued on next page


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MHS Manual for Official ControlsChapter 4: Part 1:Audit

Section 1

Introduction 1-3

Purpose, Continued

Effectiveaudit

An effective OV audit of FBOs obligations in respect of publichealth, animal health, animal welfare and animal by-productsis defined as follows:

complies with the requirements of (EC) 854/2004 todetermine the frequency of audit on the basis of risk

applies appropriate standards in determining thelevel of assurance that can be given to theCompetent Authority (MHS, FSA and Defra) aboutthe FBO management procedures and identificationof risk

accurately assess the FBOs level of compliance withlegal requirements and identifies necessary

enforcement actions recognises the FBOs good practices and identifies

opportunities for improvement communicates audit findings to the FBO and the

Competent Authority (MHS, FSA, Defra andDevolved Administrations as appropriate)

is consistent in its approach.

Determinationof frequency The frequency of audit reporting is determined on a riskbasis assessed, in part, on the outcome of previous auditsas outlined in this chapter. The scheme has five levels ofaudit frequency ranging from 2 to 12 monthly intervals.

Auditfrequencyand ceilinglevel

The table below lists the minimum audit frequenciesapplicable to all types of food establishments.

Note: 8 month audit category is effectively a Ceiling Levelfor slaughterhouses and cutting plants.

AuditCategory

Points Range Minimum Audit Frequency

12 month 0 45 At least once every 12 months8 month 50 90 At least once every 8 months5 month 95 135 At least once every 5 months3 month 140 180 At least once every 3 months2 month 185+ At least once every 2 months


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Section 1

Introduction 1-4

Relationship between OV Attendance and AuditFrequency

Overview The frequency of audit and the frequency of attendance will notnecessarily be the same. Audit frequency represents theminimum number of times a year that a completed audit reportwill be produced.

Reference: See topic Unscheduled Enforcement Visits in thesection MHS Role in this chapter for additional information.

Premiseswithfrequent OVpresence

In establishments, e.g. slaughterhouses, where OVs are

present on an ongoing basis to carry out inspection and otherduties, the audit frequency represents the minimum numberof times a year that an OV will produce a complete auditreport.

OVs who work in a slaughterhouse co-located with otherpremises may enter the other establishment regardless of theaudit timetable. However, the OV should consider theirreasons for entry and ensure that it is part of their officialcontrol role. Daily checks in co-located establishments are

not required.

Regulation: The Food Hygiene (England) (Scotland) (Wales)Regulations 2006 (as amended), Regulation 14, 2.

Premiseswithout

frequent OVpresence

In establishments without frequent OV presence, the auditfrequency represents the minimum number of times a yearthat OVs will visit and produce an audit report. The numberand duration of OV visits depends on a number of factors, forexample, the time required to:

gather evidence in support of the audit (may be done inpart by the MHI)

follow up on previous audit findings to check thatcorrective actions have been taken

undertake other official controls e.g. inspections relatingto SRM

follow up on information received or a complaint e.g.from another OV, an EHO, or from a consumer

take necessary enforcement action.



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MHS Manual for Official ControlsChapter 4, Part 1: Audit

Section 1

Introduction 1-5

Relationship between OV Attendance and AuditFrequency, Continued

Premisesw ith specific

requirements

The table below summarises the circumstances under whichspecific types of establishments operate under a differentaudit regime.

Establishment Audit regime

New start up,conditionallyapproved cuttingplants

At cutting plants, if risks are being managedappropriately, FBO audit will not commence until fullapproval is granted, otherwise the OV should conductmonitoring and enforcement visits at the specific requestof the VMHA/LV.

If risks posed require a full audit prior to the nextapproval visit, set audit frequency at 2 months until fullapproval achieved or the FBO introduces adequatecontrols and audit may be suspended until full approval.

At the visit where the VMHA recommends full approval,VMHA and LV to set audit frequency based on the FBOaudit undertaken at the time.

New start up,conditionallyapprovedslaughterhousesand gamehandlingestablishments(GHEs)

At slaughterhouses and GHEs, if risks are being managedappropriately, FBO audit will not commence until fullapproval is granted, otherwise the OV should take theappropriate enforcement action.

At the visit where the VMHA recommends full approval,VMHA and LV to set audit frequency based on the FBOaudit undertaken at the time

Premisestransferred fromlocal authorities

FBO audit will not commence until full approval isgranted, unless the joint LV / VMHA veterinary riskassessment at the first approval visit identifies risks thatrequire a full audit prior to the next approval visit.Where this is the case, set audit frequency at 2 monthsuntil full approval achieved, or the FBO introducesadequate controls and audit may be suspended until fullapproval. The OV should also conduct monitoring andenforcement visits at the specific request of the VMHA

At the visit where the VMHA recommends full approval,VMHA and LV set audit frequency based on the FBO auditundertaken at the time



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MHS Manual for Official ControlsChapter 4, Part 1: Audit

Section 1

Introduction 1-7

Relationship between OV Attendance and AuditFrequency, Continued

Premises with specific requirements, (continued)

Establishment Audit regime

Closed and re-openingpremises (within6 months)

Where the date of the next scheduled FBO audit fallswithin the period when the establishment is notoperating, the audit should be completed not later than2 months from re-commencing operations, to ensurethat at least 1 audit is conducted within each 12 monthperiod.


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Section 2

Legislation 2-1

Section 2 Legislation

Section Overview

In thissection


Topic SeePage

Requirement for Audit 2-2


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Section 2

Legislation 2-2

Requirement for Audit

Generalrequirements

for officialcontrols

It is a principle of (EC) 854/2004 that official controls willverify the FBOs compliance with (EC) 852/2004, (EC)853/2004 and (EC) 1774/2002.

Part of that verification process is the audit of good hygienepractices and HACCP-based procedures, i.e. the FBOs foodsafety management system.

In addition to the audit of good hygiene practice, the OVmust verify the FBOs continuous compliance with their ownprocedures for all aspects of animal by-product handling(including SRM control), animal identification, health and

welfare of animals, etc.

In addition to the audit of HACCP-based procedures the OVmust check that the operators procedures guarantee, to theextent possible, that meat is free from patho-physiologicalabnormalities or changes, faecal or other contamination andSRM (subject to Community rules).

Regulation: (EC) 854/2004, Article 4.

Food fraud The recommendation of the Food Fraud Task Report 2007 isthat auditors and other officials visiting food premises shouldbear in mind the possibility of fraudulent activities.Reference: Food Fraud Task Report 2007

GHP audit Audits of good hygiene practices shall verify that FBOs applyprocedures continuously and properly, concerning at least:

checks on food chain information

the design and maintenance of premises and equipment pre-operational, operational and post-operational

hygiene

personal hygiene

training in hygiene and in work procedures

pest control

water quality

temperature control

controls on food entering and leaving the establishment,and

any accompanying documentation.


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Section 2

Legislation 2-3

Requirement for Audit, Continued

HACCP audit Audits of HACCP-based procedures are to verify that FBOs areapplying procedures continuously and properly. The OV mustdetermine whether the procedures guarantee, to the extentpossible, that products of animal origin:

comply with microbiological criteria laid down under EUlegislation

comply with EU legislation on residues, contaminants andprohibited substances, and

do not contain physical hazards, such as foreign bodies.

Reference: (EC) 853/2004, Section II, Annex II.

When a FBO uses procedures set out in guides to theapplication of HACCP principles rather than establishing itsown specific procedures, the audit shall cover the correct useof these guides.

Reference: (EC) 852/2004, Article 5.


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Section 3

FBO Responsibility 3-1

Section 3 - FBO Responsibility

Section Overview

In thissection


Topic SeePage

Compliance with the Legislation 3-2HACCP Based Systems 3-3


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Section 3


Compliance w ith the Legislation

FBO

standardsThe FBO is required to comply with the requirements of (EC)

852/2004 and (EC) 853/2004. These are the standardsagainst which the OV will assess the FBO performance ataudit.

Food safety management procedures must be implementedand must be sufficient to achieve the objectives of theRegulations.

Reference: MIG, Part 1 FBO Obligations.

Role of theMeatIndustryGuide

The Meat Industry Guide (MIG) contains an interpretation ofthe EU Regulations and extensive, detailed guidance on howthe FBO may achieve effective compliance with theLegislative requirements.

Justificationofprocedures

The FBO is not obliged to follow the guidance in the MIG andmay choose to achieve compliance with the Regulations byalternative means.

The FBO must be able to provide justification for theprocedures put in place to manage food safety and hygiene,especially if these differ from the MIG.

Access,records andassistance

The FBO is required to offer all assistance needed to ensurethat official controls carried out by the competent authoritycan be performed effectively, and in particular to:

give access to all buildings, premises, installations or

other infrastructures, and make available any documentation and records required

under the Regulations or considered necessary forjudging the situation.

Regulation: (EC) 854/2004, Article 4 and The Food Hygiene(England, Scotland and Wales) Regulations 2006 (asamended).


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Section 3


HACCP Based Systems

Obligation to

implementThe FBO, considering the nature and size of the business, has

a duty to implement a permanent procedure based on the 7HACCP principles of:

identifying any hazards that must be prevented,eliminated or reduced to acceptable levels

identifying the CCPs / control points required byregulations at the step or steps at which control isessential to prevent or eliminate a hazard or to reduce itto acceptable levels

establishing critical limits / legal limits at CCPs / controlpoints required by regulations which separate

acceptability from unacceptability for the prevention,elimination or reduction of identified hazards

establishing and implementing effective monitoringprocedures at CCPs / control points required byregulations

establishing corrective actions when monitoring indicatesthat a CCP/ control point required by regulation is notunder control

establishing procedures, which shall be carried outregularly, to verify that the measures outlined above are

working effectively, and establishing documents and records commensurate with

the nature and size of the food business to demonstratethe effective application of the measures outlined above.

When any modification is made in the product, process, orany step, food business operators shall review the procedureand make the necessary changes to it.The FBO must also provide the competent authority withevidence of their compliance and ensure that any documents

describing the procedures are up-to-date at all times.

Regulation: (EC) 852/2004 Article 5 and EU guidancedocument on the implementation of proceduresbased on HACCP principles, and on the facilitationof the implementation of the HACCP principles incertain food businesses.

Reference: See MIG, Part 3, Chapter 1 Application ofHACCP based procedures and Part 2 of thischapter HACCP based procedures.



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Section 3


HACCP Based Systems, Continued

HACCP andpre-

requisites

HACCP systems are not a replacement for other food hygienerequirements, but a part of a package of food hygienemeasures that must ensure safe food. It must be borne inmind that prerequisite food hygiene requirements must bein place prior to establishing HACCP procedures, including inparticular:

requirements for infrastructure and equipment

requirements for raw materials

the safe handling of food (including packaging andtransport)

food waste handling pest control procedures

sanitation procedures (cleaning and disinfection)

water quality

maintenance of the cold chain

the health of staff

personal hygiene

training.

These requirements are designed to control hazards in ageneral way and they are clearly prescribed in Communitylaw. They may be supplemented with guides to goodpractices established by the different food sectors.

Reference: EU guidance document on the implementation ofprocedures based on HACCP principles, EUROPA - FoodSafety - Biological Safety of Food - Legislation on FoodHygiene and on the facilitation of the implementation of theHACCP principles in certain food businesses and MIG, Part 2,Chapters 1 to 15.

Note: Other requirements of Community law, such astraceability, the withdrawal of food and the duty of informingthe competent authorities should, although not covered underthe food hygiene rules, also be considered as prerequisiterequirements.

Reference: (EC) 178/2002, Article 18 &19.


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Section 4Amendment 28

MHS Role 4-1

Section 4 - MHS Role

Section Overview

In this

sectionThe table below lists the topics in this section.

Topic SeePage

Responsibilities 4-2Newly Approved Establishments 4-6Audit Schedule 4-7Audit Protocol 4-9Completing the Audit Report 4-15Audit Assessment 4-21Enforcement 4-22


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Section 4

MHS Role 4-2

Responsibilities

Who is the

auditor?The type of premises may determine who conducts the audit,

according to the following table.

Establishment Auditor

Slaughterhouses and Game Handling Establishments OVCo-located meat plants (cutting plant, meat preparations plant,meat products plant)

OV

Stand alone meat plant (cutting plant, meat preparations plant,meat products plant) (No VC removal)

OV or LV*

Stand alone cutting plant (cutting plant, meat preparationsplant, meat products plant) (VC removal) OV or LV*

Establishments approved as a Processing Plant (meat products,rendered animal fats and greaves, treated stomach, bladder &intestines and ready to eat meats) and processing ready to eatmeats

OV** orLV*

*Lead Veterinarian**OVs auditing these premises will need to have passed the MHS

Assessment of Meat Products (Ready to Eat) OV Competency

Note: Audits should be carried out by the plant OV as part of normal duties.Where a Contractor considers it necessary to use an alternative or additional OV or

requires additional time; this can only be done in exceptional circumstances andby prior agreement with the Business Manager (BM).Novice OVs (NOV) cannot undertake audit work but could carry out evidencegathering in support of the audit.

Audit tasks The following table identifies the different tasks andresponsibility for completion.

Task Responsibility

Arrange audit visit date with the FBO or theirrepresentative

Auditor

Confirm audit visit date in writing copying the letterto the Delivery Planning Unit (DPU)

Auditor

Audit preparation gathering information on FBOsfood safety management systems

Auditor

Complete Risk Factor Data AuditorGather information on food safety managementsystems

MHI / OV/ NOV



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Section 4

MHS Role 4-3

Responsibilities, Continued

Audit tasks,(continued)

Task Responsibility

Carry out audit visit including the discussion ofaudit findings and possible corrective actions withthe FBO or their representative

Auditor

Compile audit report AuditorUndertake a check of the audit report forestablishments approved as a Processing Plant(meat products, rendered animal fats and greaves,treated stomach, bladder & intestines and ready toeat meats) and processing ready to eat meats.

LV

Distribute completed audit report to FBO DPU

Auditorscode of

ethics

The following four principles are the standards of conductthat are expected from OVs carrying out FBO audits:

1. IntegrityAuditors should demonstrate integrity in all aspects of theirwork. The relationship with other OVs and with FBOs andMHIs should be one of honesty and fairness. This establishesan environment of trust which provides the basis for allactivities carried out by the auditing OV.

2. Objectivity

Auditors should display appropriate professional objectivitywhen providing their opinions, assessments andrecommendations. The OV auditor should not be undulyinfluenced by the views of others or by personal interest.

3. Competency

The OV auditor should not carry out audits if they feel theydo not have the base auditor competency or if they lacktechnical competency in the area being assessed. During theOV probationary period NOVs should focus on acquiringthose auditing competencies.

4. Confidentiality

Auditors should safeguard the information they obtain whilecarrying out their duties. There should not be anyunauthorised disclosure of information unless there is a legalor professional requirement to do so.



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Section 4

MHS Role 4-4


Auditorduties

The auditor is responsible for:

advising the FBO on compliance with legal requirements, undertaking audit activities in line with this instruction,

preparing a report for the FBO and DPU at the prescribedfrequency, and

determining an audit outcome.

Auditorexclusions

The auditor should not:

assume accountability for FBO compliance

take over tasks that are for the FBO to perform

act as a quality assurance manager act as an advocate between industry and the MHS

write company procedures or HACCP plans, althoughadvice may be given.

LV duties The LV is responsible for undertaking checks to ensureappropriate scores in Section 1.2 and evidence explaining thedecision for the scores awarded is detailed in the audit report(AUD 9.3), for establishments approved as a Processing Plant

Processing Plant (meat products, rendered animal fats andgreaves, treated stomach, bladder & intestines and ready toeat meats) and processing ready to eat meats.

Reference: See Section 5 Risk Assessment

MHI duties MHIs working regularly in an establishment must ensure thatthey are familiar with the procedures put in place by the FBO.This will necessitate that they know the contents of anywritten procedures relevant to the processes for which theyhave an inspection role.

Note: The auditor must ensure that MHIs working under theirresponsibility maintain a current understanding of the FBOsprocedures.



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Section 4

MHS Role 4-5


DeliveryPlanning Unit

(DPU)administrationduties

DPU will:

monitor the scheduling of the audit visits inaccordance with the minimum audit frequencydetermined by the audit category,

monitor the timely production of audit reports,

distribute the completed report to the FBO,

maintain audit records, and

issue appeal forms to FBOs, as requested.


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Section 4

MHS Role 4-6

New ly Approved Establishments

Introductory

meetingBefore first auditing an establishment, or if the FBO

responsible for the establishment has changed since the lastaudit, the auditor should hold an introductory meeting withthe FBO to discuss the following points:

an overview of the Regulations, any changes sinceprevious audits and the FBOs responsibilities

introduction to the MHS Manual for Official Controls andamendments

outline the MHS enforcement policy and possibleoutcome of the audit

role of the Guide to The Food Hygiene and OtherRegulations for the Meat Industry (Meat Industry Guide)

audit role of the auditor, powers of entry (whennecessary)

risk assessment (including validation of risk data) andaudit frequency arrangements

audit process and timetable

reporting arrangements, including publication of theaudit category


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Section 4

MHS Role 4-7

Audit Schedule

Arranging

visitsThe auditor will contact the FBO one month in advance of the

audit being due (two weeks notice is acceptable but not bestpractice) to agree a date for the audit visit.

The scheduling of the audit visits will be monitored byDPU/BM in order to ensure that audit targets and frequenciesare met.

The agreed date of the audit visit must be confirmed inwriting by the auditor to the FBO. This letter will provide theFBO with prior warning of an audit; outlining the scope of the

audit and the access and information that will be required.Regulation (EC) 882/2004, Article 3, Paragraph 2

Reference: See MHS Intranet - FBO Audits for templateletter.

Notification of the audit will allow the FBO to makethemselves, or their relevant members of their managementteam available. In addition, it allows the FBO to have anynecessary documentation available for audit.

Auditor /Contractor

tasks

The following tasks are the responsibility of the auditor:

arrange the audit visit with the FBO

complete the audit within the calendar month of thedesignated audit frequency

complete the report and return it to DPU within 10working days of the audit visit. DPU will then arrange forlogging and distribution, including to the FBO and BM.

Target forsubsequentaudit

completion

Subsequent audit visits will be within the month determinedby the last audit category.



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Section 4

MHS Role 4-8

Audit Schedule, Continued

Alternativearrangements

Where the audit date has been scheduled with the FBO andthe FBO wishes to cancel/rearrange, the auditor/contractorshall inform the BM of the agreed audit date and inform DPUof the re-scheduling to assist with the tracking.

Where an auditor/contractor anticipates that they are unableto complete the audit visit within the required timescale, theauditor or contractor must inform the BM without delay, sothat alternative arrangements can be made.


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Section 4

MHS Role 4-9

Audit Protocol

Audit

notificationThe FBO must be given prior warning of an audit; this should

be done in writing, outlining the scope of the audit and theaccess and information that will be required.Regulation (EC) 882/2004, Article 3, Paragraph 2.

Reference: See MHS Intranet - FBO Audits for templateletter.

Notification of the audit will allow the FBO to makethemselves, or relevant members of their management team,available. It also allows the FBO to have any necessary

documentation available for audit.

Note: Where there are areas of concern regarding the FBOslevel of compliance unannounced visits may take place duringwhich evidence may also be gathered for the subsequentaudit. These may be arranged through the BM.

Reference: See topic Unscheduled Enforcement Visits in thissection for additional information.

Collectingevidence asto thecomplianceof the FBO

In slaughterhouses: MHS staff are present everyday theplant operates. As part of day to day business they shouldrecord objective evidence as to the level of compliance by theFBO with both his own procedures and with legislativerequirements.

In cutting plants: MHS staff will normally only be present toconduct the audit so objective evidence will only be collectedduring the audit.

Both the OV and MHI have an important role to play inidentifying and recording non-compliances.Objective evidence of non-compliance issues may berecorded:

on the relevant operational form

in the daybook

in the enforcement programme.Note: weak or poor FBO controls should be acted onimmediately.



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Section 4

MHS Role 4-10

Audit Protocol, Continued

Assessmentof

operationalrecords

Prior to the audit, the auditor must review operationalrecords,including hygiene, welfare, animal by products andenforcement forms, for the period since the last audit and usethis information when assessing the effectiveness of the FBOsfood safety management procedures and HACCP basedsystem, taking account of corrective actions.

The auditor should consider documentary evidence, previousaudit reports and enforcement for the preceding 10 monthswhen assessing confidence in management.

Reference: See subtopic FBO Compliance History in Section

5 for additional information.

The openingmeeting

Start each audit with an opening meeting with the FBO (orappropriate representative) and outline the:

reason for the audit,

scope of the audit,

review of the Corrective Action Report (CAR) from thelast audit,

anticipated length of the audit and the plan, information and access that will be required,

purpose of the closing meeting, and

publication of audit categories.



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Section 4

MHS Role 4-11


Whencarrying out

the audit

During the audit, the auditor:

completes the Risk Assessment Data to reflect currentcircumstances

collects and records objective evidence of the FBOscompliance with legislative requirements for food safetymanagement procedures based on HACCP principles,including animal by-product and where appropriate, SRMprocedures

Note: In slaughterhouses some of this information will begathered on a daily basis by MHIs/OVs.

inspects the establishment (reality checks) to observewhether the FBOs procedures in practice reflect thepolicies and procedures as documented

assesses the FBOs procedures using the MHS OperationalRecord, in particular:monitoring activities and related records corrective actions and related records

determines overall outcomes as good, adequate,weak or poor.

Seriousissuesidentifiedduring audit

If an issue of serious public health, animal health or welfarearises during an audit (e.g. considered poor), the auditorshould:

inform the FBO and the BM immediately

take any necessary enforcement action

consider curtailing the current audit.



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Section 4

MHS Role 4-12


Audit notes It is important that audit notes are taken during the audit asthey constitute an essential element to support the OV auditfindings and justify the audit assessments.

Audit notes should be kept in a page numbered notebook andeach page must

have the audit number which compromises the four digitapproval number, site type and audit date (month/year),e.g. xxxx-SH-mm/yy

contain contemporaneous, detailed and legible noteswhich are cross-referenced to the aide memoir referenceof the AUD 9/3 form

be dated and signed by the auditor

Audit notes do not need to be submitted with the audit reportbut they should be retained and made available to a newauditor when a different auditor is going to be conducting thenext audit.Audit notes must be retained for a minimum of 2 years (morethan 2 years if there are ongoing outstanding enforcementactions).

FBO

involvementin Audit

The auditor should expect to be accompanied by the FBO (ora nominated representative) throughout the audit.

The closingmeeting

The audit must be concluded with a closing meeting with theFBO (or appropriate representative) which will:

summarise the audit findings (positive and negative),

outline any non-compliances, discuss the corrective action required, including any

proposed timescales and possible enforcement action,

discuss the confidence in FBOs food managementsystems score, and

give an indication of the expected future audit category

give details of report procedure,

give details of publication of the audit categories, and

outline subsequent action and right of appeal.



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Section 4

MHS Role 4-13


The closing

meeting,(continued)

The closing meeting provides an opportunity for the FBO to

respond to audit findings, to discuss his proposed actions andto provide any further supporting evidence if he disagreeswith any audit findings.

It may be appropriate to allow the FBO a short period of timefollowing completion of the audit to provide anydocumentation not available at the time or to demonstrateimmediate action taken to correct deficits identified.

Auditorwrittenreport

The written report (form AUD 9/3) must be compiled fromthe audit findings and should not be materially different fromthe findings presented verbally during the closing meeting.

The report must be sent to DPU within 10 working days of theaudit visit.

Reference: See the topic Completing the Audit Report inthis section for additional information.



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Section 4

MHS Role 4-15

Completing the Audit Report

Format and

purposeThe Audit Report may be assessed by the BM/LV to ensure

consistency of reporting and will also be available to Internal(VAU) and external (FSA or FVO) Auditors.During subsequent audits, the auditor should refer to theprevious Audit Report to direct priorities during audit in a riskbased manner, especially areas assessed as weak or poorthat will always have to be reassessed in the next audit.

The audit report (AUD 9/3) contains several sections asoutlined in the table below:

Audit ReportSections Contains

Establishment,Audit, Auditorand FBODetails

Establishment details: Approval number Name and address of the establishment Type of establishment Approval status Approval matches plant activities

Audit details:

Audit number Time spent during audit preparation, audit visit and

report writing Previous audit date and category Number of follow up enforcement visits since

previous audit

Auditor details Name, telephone and e-mail of the auditor

conducting the audit

FBO (or their representative) details

Name and position Name of others attending the audit

Summary Corrective actions completed since the last audit Include the corrective action reference from the last

audit and details of the achieved complianceoutcome

Audit findings Include positive and negative findings



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Section 4

MHS Role 4-16

Completing the Audit Report, Continued

Audit ReportSections

Contains

Part 1Risk Factors

1.1 Potential hazards: Microbiological hazards Chemical hazards Physical hazards

1.2 Type of process carried out1.3 Vulnerable consumers potentially at risk1.4 Throughout

Part 2FBO Actions

2.1 Animal health risks of public health significance:

FBO controls on incoming animals including Food ChainInformation (where available)

Other FBO controls to minimise potential spread ofanimal diseases

2.2 Animal welfare:

Lairage conditions and animal handling

Slaughter procedures including training of operatives

Ritual slaughter

FBO action on welfare issues

2.3 Hygienic production including

Slaughter and dressing TSE controls

Cutting/processing of meat/co products

Transport/ re wrapping/ re packaging/ storage ofproduct

Further handling of ABP/ waste2.4 Environmental Hygiene:

Structure

Water supply

Maintenance Cleaning

Pest control

Staff training/ instructions and supervision

Staff health and hygiene

A detailed summary of compliance/ non-compliance

Evidence to support auditors assessments



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Section 4

MHS Role 4-17



Contains

Part 2FBO Actions,

cont

2.5 Confidence in FBOs food safety management systems tocontrol hazards

Application of HACCP based procedures, includingmicrobiological verification, if appropriate

HACCP training

For the above criteria the auditor must provide:

An assessment (good, adequate, weak or poor)

CorrectiveAction Report

(CAR)

Corrective actions required including an agreed orsuggested timescale (target completion date) and the levelof priority:

High priority(H) relates to non conformitieswhere immediate and specific risks must bemanaged by the FBO:

In the area of animal welfare this wouldrelate to immediate and specific risk ofunnecessary pain and/or unnecessarydistress

In the area of public health it will relateto immediate and specific risk inrelation to hazards causing foodborneillness

In the area of animal health it will relateto poor FBO controls to deal with animalhealth controls.

Medium priority (M) relates to non conformitiesthat require attention as they may affect the

achievement of FBO processes or food safetymanagement systems. These include areas where: If action is not taken, over time a more

serious level of risk might arise Where an actual risk would occur only if

there was a cumulative failure in thisnon conformity and others



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Section 4

MHS Role 4-19


Verificationof

compliance -Part 2

Use the relevant legislation, the Meat Industry Guide and theManual for Official Controls to verify FBO compliance with therequirements of EU and national legislation. For example:

Requirements of the Animal By-Products (Identification)Regulations 1995 (as amended) (identification andstorage of ABP)

Requirements of Regulation (EC) 999/2001 (removal,identification and storage of SRM)

Requirements of Regulation (EC) 1774/2002 (collectionand disposal of ABP & SRM)

The Meat Industry Guide identifies the individualrequirements of the legislation. This will assist both theauditor and FBO in referencing the industry guidance.

Note: The use of the guidance in the Meat Industry Guide bythe FBO is voluntary and the FBO systems/ procedures maybe different to the ones described in the Meat Industry Guidebut they may be valid to achieve compliance with thelegislation.

Note: The parts of the report requiring completion willdepend on the nature of the food business i.e. slaughter /cutting and the species handled.


Each section of the FBO actions of the audit report (Part 2)contains a set of statements that reflect outcomes in the MHSpriorities agreed by MHS, FSA and Defra.

The purpose of the statements is to improve a structure for

the audit report. The audit section lists are not exhaustiveand OVs may consider other areas that require auditing.

Any areas assessed as weak or poor in previous auditsalways have to be assessed during the next audit.

Use ofobjectiveevidence

As the formal record of the audit findings, the audit reportmust reflect objective evidence to support the overall findingsof the audit and the results given to the FBO during theclosing meeting of the audit visit.



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Section 4

MHS Role 4-20


Use ofpositive

language

The OV should use positive language during the closingmeeting and in the audit report.This will help to promote constructive communication of auditfindings between the OV and the FBO, better participationand resolution of non-compliances through joint identificationof action and opportunities for improvement, which is themain aim of the audit.

Publicationof FBOs auditreport

The Freedom of Information Act 2000 gave individuals ageneral right to information held by public authorities(subject to certain exemptions) and to have this information

communicated to them. The Environmental InformationRegulations 2004 also provides a right of public access to arange of environmental information held by public authorities.

Important note: Audit reports have been disclosed inresponse to requests made under the above legislation(except for commercial details and a small amount of otherinformation).

It is therefore important that reports are written with thepossibility of publication in mind [subject to further

consultation all audit reports may published electronicallyonce finished].


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Section 4

MHS Role 4-21

Audit Assessment

Compliance

audit andSystemsbased audit

An effective audit of FBO controls will require the use of both

compliance audit and systems based audit techniques,they are described below:

Audittechnique

Description

Complianceapproach

This is a review and examination of FBOrecords and activities to assess compliancewith legislative requirements and the FBOsestablished policies and operationalprocedures.

Much of the audit work to support complianceassessment will take place in the operationalenvironment. In establishments where thereis frequent OV presence this assessmentwork will be ongoing as part of the MHSteams normal duties between the productionof audit reports.

Systemsbased

approach

The auditor should seek to establish that theFBOs controls are fit for purpose and that the

FBO has effective systems and processes inplace to implement them on a continuousbasis. Weaknesses and strengths in the FBOscontrol system should be recorded.

Much of the audit work to support thesystems assessment is likely to take placeoutside the operational environment.

Recordingcompliance Each part of the audit report requires the auditor to gatherevidence regarding the level of compliance with the stated

outcomes and record it as good, adequate, weak or poor.

Furtherinformationprovided bythe FBO

The FBO may provide additional evidence following discussionat the closing meeting. Provided this evidence is received bythe auditor within 5 working days of the audit, it may betaken into consideration.


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Section 4

MHS Role 4-23

Enforcement, Continued

Unscheduledvisits

An unannounced enforcement visit may take place whenthere is reason to believe that an FBO is not meetingregulatory requirements. This could arise from a foodcomplaint, an audit outcome or ongoing enforcement.

Before undertaking such an enforcement visit the OV orauditor must discuss with an LV, the circumstances of thecase, the actions they intend to undertake, the relevanttimescale and the intended outcomes.

The LV will then assess, based on the evidence provided, theneed for such a visit relative to the risk and whether it is

reasonable and proportionate and advise the OV or auditoraccordingly.

The agreed actions must then be notified to the relevant BMby the OV or auditor before proceeding with the enforcementvisit.

When it is identified that enforcement or enforcement visitsresult in the MHS incurring additional costs this time may bechargeable to the FBO. BMs will authorise any additional

charges to be levied prior to the enforcement visit.

Enforcement visits must take place as necessary and may beunannounced.

Regulation: (EC) 882/2004 Article 3, Paragraph 2.

SINP code When the FBO fails to comply, which leads to the MHS havingto carry out additional monitoring and enforcements actions

as an additional cost to the MHS, the time spent by the OV inthose activities shall be charged as an Additional Charge tothe FBO as SINP?

However, regardless of the additional cost or inefficiencythe levying of additional charges should be consideredreasonable.


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Section 5

Risk Assessment 5-1

Section 5 - Risk Assessment

Section Overview

In thissection


Topic SeePage

Audit Report 5-2Risk Factors - Points Awarded 5-4FBO Actions - Audit Risk Assessment 5-9

Confidence in FBOs Food Management Systemsto Control Hazards 5-12

Review and Right of Appeal 5-17


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Section 5

Risk Assessment 5-2

Audit Report

Report Form See MHS Intranet - AUD Forms for copy of the audit report

form (AUD 9/3).

Summary offindings

The report contains an area to summarise the audit findings.The summary of findings shall include positive findings (goodpractice), negative findings (non-compliances) and a briefdescription of any variations from the previous audit enablingthe FBO and other interested parties to review the auditwithout needing to read the full detail contained within thereport.

CorrectiveActionReport (CAR)

At the end of the audit report there is a Corrective ActionReport (CAR). The CAR contains 2 sections as described inthe following table.

The CAR enables the OV to clearly inform the FBO of areasidentified as requiring corrective action and timescales forcompletion. Timescales for completion have to be discussed,and when possible, agreed with the FBO at the closingmeeting.

Once the FBO receives the report with the CAR, the FBO isresponsible for completing the corrective action taken and thedate completed, sign the form and return it to the OV orpresent it at the next audit.

The CAR also allows MHS managers to identify issues thatmay require follow up visits.

Section

completedby

Contains

Auditing OV Corrective Action Reference

Corresponding section of report

Target completion date

Corrective action requiring a follow-upvisit

FBO orRepresentative

Corrective action taken

Date completed



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Section 5

Risk Assessment 5-3

Audit Report, Continued

Completionof corrective

actions

During the next audit the OV has to verify whether the FBOhas taken corrective action and those have been completed.

Parts of theAudit Report

The audit report contains two parts that have to be assessedand scored to obtain a final score that determines the auditfrequency.

Part Score

Part 1 Risk Factors

1.1 Potential Hazards

1.2 Type of Process1.3 Vulnerable Consumers1.4 Throughput

Part 1 Risk Factors Total Score

Part 2 Food Business Operator Actions

2.1 Animal Health Risks of Public HealthSignificance2.2 Animal Welfare2.3 Hygienic Production

2.4 Environmental Hygiene2.5 Confidence in FBOs Food ManagementSystems to Control Hazards (including HACCP)

Part 2 FBO Actions Total Score

Audit Risk Assessment Final Score Score

Part 1 Risk Factors Total ScorePart 2 FBOs Actions Total Score

Final Score


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Section 5

Risk Assessment 5-4

Risk Factors Points Aw arded

Entering of

Risk FactorsThe auditor must enter the risk factors at the audit based on

the activities carried out by the FBO during the last auditperiod, rather than the establishments approval; e.g. anestablishment may be approved to slaughter 3 species but ifonly one species has been slaughtered during the last auditperiod, no extra points should be scored.

PotentialHazards

The risk scores allocated in this section are pre-set,dependent upon the likely hazards in the establishment basedon the plant activities carried out during the last audit period,as indicated in the following table.

Note: Due to the potential hazards most fresh meat plantswill be awarded a total of at least 45 points and will thereforenot be eligible to be in Audit Category 12 months.

AwardGuidance on assessment

30 Potential for microbiological hazards i.e. contamination, cross-contamination, growth and/or survival of pathogenic or spoilage

bacteria, viruses, parasites, and fungi, in or on the product.5 Only frozen products handled.

Award Guidance on assessment

10 Potential for chemical hazards i.e. contamination of meat fromresidues of veterinary products/pesticides/feed additives, as wellas from packaging and/or careless use of chemicals (e.g. cleaningproducts, disinfectants, lubricants).

5 Some potential (e.g. animals/meat from assured sources,therefore potential contamination is from packaging/productionenvironment only).

0 Only ready-wrapped products handled.


5 Potential for physical hazards i.e. contamination of meat byforeign bodies.

0 Only ready-wrapped products handled.



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Section 5

Risk Assessment 5-5

Risk Factors Points Aw arded, Continued

Type of

processcarried out

The table below indicates the risk scores allocated to

premises dependant upon the processes carried out by theFBO during the last audit period.

If any process is carried out on a specific day of the weeknote this down in the evidence section so it is taken intoconsideration at future audits.

Note: Activity types (a)-(c) must be assessed independentlyeven if they occur in combined premises. Other combinationsmust be assessed together if handled in one establishment

site.

Handling ofRTE products

When activity (d) is recorded at +25 points, the OV mustmake specific comments (in the evidence box at part 2.5of the AUD 9/3) on the FBO controls of RTE meat products.

Activity (d) might not apply to premises that only buy in andstore pre-packed ready-to-eat products. OVs must ensurethat there is no further processing and that the product is

stored correctly posing no risks.

When the OV considers that there is no risk they mustcomplete the Section 1.2 of AUD 9/3 and in the evidence boxat part 2.5, explaining why it was decided not to add the +25points, describing exactly what happens to the product andexplaining that, on that basis, the auditor considers that itseems reasonable not to add this as a further risk. Thisdecision may be challenged and will need documentary backup.

To aid OVs with the identification of RTE products furtherguidance has been provided in the portal under theFrequently Asked Questions sectionhttp://intranet/C9/C14/Frequently%20Asked%20Questions/default.aspx

Contract OVs auditing this premises will need to have passedthe MHS Assessment of Meat Products (Ready to Eat) OVCompetency



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Section 5

Risk Assessment 5-6


Risk Scoresallocated

Activity Guidance on assessment

a) Slaughter +0 if only one group of species slaughtered+5 for each other additional red meat grouped specieshandled, and+5 if handling only sheep/goat SRM or+10 if handling only cattle SRM or cattle and sheep/goatSRM

b) Dressing of Game +0 if handling either mammals or birds+10 if handling both mammals and birds

c) Cutting of meat +0 if only either red, white or game meat is cut+5 if cutting more than one type of meat(red/white/game), and+5 if handling SRM

d) Handling ready-to-eat products

+25

e) Production of MeatProduct

+10

f) Production of MeatPreparations

+5

g) Production of MSM +5

h) Production ofMinced meat

+15

i) Re-wrapping/ Re-packaging

+5

j) Cold storage +0

Species For the allocation of the score, the different species have tobe grouped as described in the following table.

If only one group of species is slaughtered (e.g. bovine) nopoints has to be scored. For each additional groupslaughtered 5 points have to be added (e.g. if bovine, ovineand porcine are slaughtered, add 10 points).

Group Species included

Bovine Cattle, calves, buffalo and bisonOvine and/or caprine Sheep and goatsPorcine Finished pigs (fattening), cull pigs

(adult boar/sow) and farmed boar

Others Horses, deer and othersContinued on next page


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Section 5

Risk Assessment 5-7


VulnerableConsumers

potentially atrisk

Most establishments supplying raw meat have the potentialto supply vulnerable consumers either directly or indirectly.

Situations where such supply is unlikely include suppliers ofgame or where the supply is to approved meat productsmanufacturers.

The lack of sale to vulnerable consumers has to be proved bythe FBO to the auditor.


0 Meat supplied (directly or indirectly) is not likely to be served togroups of 20+ vulnerable people (e.g. hospital, day care centre,nursing home) and/or it will be further processed in approvedmeat product manufacturing establishments.

20 There is uncertainty about the population who may be suppliedwith the meat and the nature of the process it may receive beforeit reaches the consumer.

Throughput This relates to number of consumers potentially at risk.

Note: The thresholds for slaughterhouses and cutting plantsare as used for HACCP implementation where large coveredabout 75% of UK production and 25% of UK plants.



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Section 5

Risk Assessment 5-8



5 Very small (i.e. equivalent to previous low throughputslaughterhouses and cutting plants), likely to market locally.

15 Small/Medium throughput not in other two categories (default formeat processors until size known).

20 Average weekly throughput above 500 livestock units or 200,000birds in a slaughterhouse / over 150 metric tonnes cut meat,likely to market nationally.


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Section 5

Risk Assessment 5-9

FBO Actions - Audit Risk Assessment

FBO

compliancehistory

The history of compliance relates to the deficiencies

identified against legislative requirements for the FBOs ownprocedures and requiring OV intervention during the auditinterval or previous available audits.

Note: FBO initiating corrective actions where the FBO hasidentified a breakdown in controls is a sign of a healthycontrol system.

During the audit, the auditor will record evidence of the FBOcompliance history, which will result in a risk score under

each category based on the following criteria:

Assessment Guidance on assessment of compliance history

Good

Active compliance with statutory requirements no actionnecessary.

procedures effective

HACCP based principles applied satisfactorily

Adequate

Occasional lapses in FBO compliance with statutory

requirements in the audit period where there were nosignificant implications for public health or animal welfareand following OV intervention:

FBO procedures required minor corrections HACCP based principles generally applied, only

minor corrections needed.

Weak

Frequent intervention by OV in the audit period to gainFBO compliance with statutory requirements where:

FBO procedures were inadequate

HACCP based principles were inadequately applied action by FBO was necessary to avoid formal

enforcement action

and the above gave rise to significant implications forpublic health and/or animal welfare.



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Section 5

Risk Assessment 5-10

FBO Actions - Audit Risk Assessment, Continued

Assessment Guidance on assessment of compliance history

Poor

Regular intervention by OV in the audit period to gainFBO compliance with many statutory requirementswhere:

FBO procedures seriously flawed or non existent

HACCP based principles not applied

immediate enforcement action is necessary.and cumulatively the above gave rise to the potential forserious risk to public health and/or animal welfare.

Or there was a breakdown in specific FBO controls that

actually caused: immediate serious risk to public health, or

an animal to sustain avoidable excitement, pain orsuffering

Applicableareas

The above criteria will be applied to the following auditcategories:

animal health risks of public health significance

animal welfare

hygienic production environmental hygiene.

Animalhealth risks

of publichealthsignificance

The assessment will reflect the outcome of audits on FBOpractices including:

FBO controls on incoming animals including Food ChainInformation (where available)

Other FBO controls to minimise potential spread ofanimal diseases

Scores allocated for each assessment are as follows:

Note: This category will only apply in slaughter and wildgame processing establishments.

Assessment AwardGood 0

Adequate 5Weak 15Poor 25



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Section 5


FBO Actions - Audit Risk Assessment, Continued

Animalwelfare

FBO compliance with requirements for animal transport,lairaging, handling, stunning, killing and bleeding, includingritual slaughter.

Note: This category will only apply to slaughterestablishments.


Adequate 5

Weak 10Poor 15

Hygienicproduction

FBO compliance with regulations for dressing, cutting,processing, handling (wrapping, packaging, storage andtransport) practices and procedures, TSE controls, ABP andtemperature control.

Assessment AwardGood 0Adequate 5

Weak 15Poor 25

Environment-al hygiene

FBO compliance with requirements for: structure, watersupply, maintenance, cleaning, pest control, stafftraining/instructions and staff health and hygiene.


Adequate 5Weak 15Poor 25


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Section 5


Confidence in FBOs Food Management Systems toControl Hazards

Allocation ofConfidence inFBOs FoodManagementSystems

The score allocated will reflect the outcome of audits of FBOcontrols.

The main component for the OV assessment of this sectionof the audit report is the continuous and correct applicationof HACCP based procedures by the FBO.

AssessmentofConfidence

in FBOs FoodManagementSystems.

To determine when the next audit visit/report will be, theaudit category of the premises has to be established. The

auditor must make an assessment of Confidence in FBOsFood Management Systems.

In order to make this assessment, the auditor must takeaccount of :

evidence of best practices implemented by the FBO

non-compliances raised during the audit period

the effectiveness of FBO actions to correct these non-compliances

FBO response to any enforcement taken during the auditperiod

the FBO response during the closing meeting to issuesraised during the audit.

The proposed Confidence in FBOs Food Management Systemsscore should be discussed with the FBO during the closingmeeting, and confirmed with objective evidence in the writtenreport.

Note: The items listed are areas that the auditor shouldconsider when making the judgement, not a detailed orexhaustive list of requirements to be met.



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Section 5


Confidence in FBOs Food Management Systems toControl Hazards, Continued

Assessment Guidance on assessment

Good:

Award 0

FBOs demonstration of competency regarding hygiene andfood safety gives high confidence that hazards will becontrolled on an ongoing basis. e.g.:

compliant in all audited areasor only few OVinterventions required

HACCP plans kept under review

HACCP based principles embedded into staff routines,

particularly with regard to monitoring and correctiveaction

fully documented policies and procedures are in place toensure continuing good hygiene practices, particularlywith regard to staff training, cleaning and maintenanceprocedures

accredited to quality assurance schemes and subject tothird party audits. Act immediately on complaints

actively seek advice

rarely obtain poor microbiological test results

active compliance with statutory requirements none orfew OV actions necessary.

Adequate:

Award 5

Management attitude to hygiene and food safety givesreasonable confidence that hazards will be controlled on anongoing basis. The auditor has evidence that:

the FBO is complying with regulatory requirements inmost audited areas

where there have been areas out of control, the FBOscorrective actions have been, or are being, applied

appropriately and effectively FBO procedures require minor corrections

Occasional lapses in FBO compliance with statutoryrequirements in the audit period where there were nosignificant implications of public health and/or animalwelfare.



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Section 5



Assessment Guidance on assessment

Weak:

Award 15

Attitude to hygiene and food safety gives little confidencethat hazards will be controlled on an ongoing basis. Theauditor has evidence of:

FBO procedures inadequate in many audited areas

numerous inadequate FBO procedures that collectivelyindicate a trend towards loss of control

deficiencies are identified by the FBO but not effectivelymanaged

HACCP based principles inadequately applied

Frequent intervention by OV in the audit period to gainFBO compliance with statutory requirements wherethere were significant implications for public healthand/or animal welfare.



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Section 5



Assessment Guidance on assessmentPoor:

Award 30

Management attitude to hygiene and food safety givesminimal confidence that hazards will be controlled on anongoing basis.The auditor has evidence of one or more ofthe following:

unsatisfactory application of HACCP based principles,particularly with regard to monitoring and correctiveaction

few policies and procedures in place to ensure

continuing good hygiene practices, particularly withregard to staff training, cleaning and maintenanceprocedures

unwillingness to act on complaints, previous advice andenforcement

failure to act on poor microbiological test results

Inadequate FBO procedures in many audited areas andare reasonably likely to lead to exposure of humans oranimals to an unacceptable level of hazard (e.g. poor orunacceptable FBO controls that require immediate OV

intervention) required records are absent, incomplete or have been

altered, to a degree that means the auditor has noconfidence in the system being audited

FBOs monitoring procedures repeatedly fail to identifyserious deficiencies

a specific breakdown of FBO controls that actuallycaused: immediate serious risk to public health an animal to sustain avoidable excitement, pain or

suffering

Frequent intervention by OV in the audit period to gain FBOcompliance with many statutory requirements where therewere potential serious risks for public health and/or animalwelfare.



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Section 5



Assessmentof HACCP

basedsystem

Whilst assessing the effectiveness of the FBOsimplementation of HACCP principles, the auditor should haveregard to the guidance contained in:

the HACCP chapter of the MIG

the Meat Plant HACCP Manual

the EU guidance document on the implementation ofprocedures based on HACCP principles, and on thefacilitation of the implementation of the HACCP principlesin certain food businesses.

The audit should validate the accuracy and fitness forpurpose of the HACCP based procedures plan and verifyeffective implementation.

Reference: Further guidance is included in the MIG HACCPchapter.


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Section 5


Review and Right of Appeal

FBO right to

seek reviewIf an FBO is dissatisfied with the outcome of discussions with

the OV after the review meeting, or the audit report oncereceived from DPU, the FBO has the right of appeal in linewith the following procedures:

Step Action

Try toresolveinformally

All efforts should be made to resolve any misunderstanding ordissatisfaction informally on a local basis

Direct FBOto DPU to

request anaudit appealform

If a FBO, or their representative, still wishes to appeal an auditreport they should be directed to the DPU audit co-ordinator to

request the audit appeal form Request for a review of theAudit of the FBOs Food Safety Management System

FBO submitsformalappeal, withsupportingevidence

The FBO, or their representative, should complete their part ofthe form, stating which sections of the audit report the FBO isappealing against and giving objective evidence to support theclaim that the auditors assessment is incorrect. Anysupporting evidence should be copied and sent with the formto the audit co-ordinator within 28 calendar days of receivingthe initial audit report from DPU.

InvestigatingOfficer (IO)appointed

On receipt of the completed appeals form DPU will inform therelevant BM and provide them with a copy of the appealincluding any supporting evidence. The BM is then responsiblefor appointing an Investigating Officer (IO)

IO conductsaninvestigation

The IO conducts an investigation and completes a reportbefore the last date for completion (stated in part 1 of theappeal form).

Investigationoutcome On conclusion IO distributes IO report and audit report to theFBO, OV & Contractor and DPU (cc BM and LV). The IO isresponsible for discussing the investigation findings with theauditing OV and the FBO (or their representative) regardless ofwhether the audit report resulted in an amended or the scorewas upheld.The IOs decision is final but if FBO is dissatisfied by the meansin which the appeal was undertaken by the MHS (not theoutcome of the appeal) the MHS Complaints Procedure isavailable.


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Annex 1

1

Examples of Completed Risk Assessments

Cutting P lants

1

WhiteMeat

2.

Red Meat(no SRM)

3.

Red Meat(SRM handled)

4.

White &Red(no SRM)

5.

White & Red(SRMhandled)

A. Risk Factors

Type of hazard 45 45 45 45 45Process type

Species 0 0 0 5 5SRM 0 0 5 0 5

VulnerableConsumers

0/20 0/20 0/20 0/20 0/20

Throughput

V Small + 5 50 / 70 50/ 70 55/ 75 55/ 75 60/80Small/Med + 1 5 60 / 80 60/ 80 65/ 85 65/ 85 70/90Large 2 0 65 / 85 65/ 85 70/ 90 70/ 90 75/95

B. FBOs Actions Excellent Acceptable Poor UnacceptableHygienic prod. 0 5 15 25Env. hygiene 0 5 15 25Confidence inManagementSystems

0 5 15 30

Total 0 15 45 80

Sa m p le o u t c o m e s Po ints Ranges for cutting plant examplesin Column 1 (min) & Column 5 (max) above

A+B Total Excellent Acceptable Poor Unacceptable

Very Small 50/ 80(8 m Cat)

65/ 95 95/ 125 130/ 160(5 m/ 3 m Cat)

Small/ Medium 60/ 90

(8 m Cat)75/ 105 105/ 135 140/ 170

(3 m Cat)Large 65/ 95

(8 m/ 5 m Cat)80/ 110 110/ 140 145/ 175

(3 m Cat)



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Annex 1

2

Examples of Completed Risk Assessments

Slaughterhouses

1.Pigs orPoultry

only

2.Sheeponly

3.Cattleonly

4.Pigs &Sheep

5.Pigs &Cattle

6.Sheep &Cattle

7.3 redmeat

speciesA. Risk

Factors

Type ofhazard

45 45 45 45 45 45 45

Process typeSpecies 0 0 0 5 5 5 10

SRM 0 5 10 5 10 10 10VulnerableConsumers

0/20 0/20 0/20 0/20 0/20 0/20 0/20

ThroughputV Small + 5 50 / 70 55/ 75 60/ 80 60/ 80 65/ 85 65/ 85 70/90Small/Medium + 1 5

60 / 80 65/ 85 70/ 90 70/ 90 75/ 95 75/ 95 80/100

Large + 2 0 65 / 85 70/ 90 75/ 95 75/ 95 80/ 100 80/100 85/105

B. FBOs Actions Excellent Acceptable Poor UnacceptableAnimal health 0 5 15 25

Animal welfare 0 5 10 15Hygienic prod. 0 5 15 25Env. hygiene 0 5 15 25Confidence inManagementSystems

0 5 15 30

Total 0 25 65 120

Samp le

o u t c o m e s

Points Ranges for slaughterhouse examples inColumn 1 (min) & Column 7 (max) above

A+B Total ExcellentAcceptable

Poor

Unacceptable

Very Small 50/ 90

(8 m Cat)75/ 115 120/ 160 170/ 210

(3 m/ 2 m Cat)Small/Medium

60/ 100

(8 m/5 mCat)

85/ 125 130/ 170 180/ 220(3 m/ 2 m Cat)

Large 65/ 105

(8 m/ 5 mCat)

90/ 130 135/ 175 185/ 225(2 m Cat)


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Annex 2

1

Co-located Cold Store Aide Memoire

Areas for

considerationWhen auditing FBO food safety management systems in co-

located cold stores the following areas are to be considered:

1. Structure,Layout &

Equipment

Effective refrigeration equipment constructed andmaintained to avoid contamination of, or contact with,meat?

Appropriate temperature recoding equipment installed? Records retained for an appropriate period? Practices ensure that long periods of temperature rise

in cold rooms are avoided? Adequate facilities/systems to prevent accumulation of

ice/snow (frozen condensation)? Doors seals tight? Doors closed when not in use Use of strip curtains Others systems to prevent ingress of warm air

2. Storage All meat kept off the floor?o Packaged meat wooden pallets are strongly

constructed racking system?o Packaging sufficient enough to protect meat

during storage?o Exposed carcase meat overhead rails or metal

frames and hooks?

Sufficient number of chambers?o To ensure meat intended for human consumption

is not held in the same chamber as unfit meat ormeat not intended for human consumption?

o Adequate separation from unfit meat, othermeats, packaged/unpackaged, other products?

Meat maintained at, or below, requiredtemperatures throughout period of storage?



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Annex 2

2

Co-located Cold Store Aide Memoire, Continued

2. Storage,(continued)

Cold stores approved to handle only fully wrapped or

packaged meat Adequate reception and despatch facilities to protect

packaged meat? Wrapping and packaging sufficiently robust to prevent

exposure of the meat?

Cold stores approved to handle unwrapped or wrappedmeat not packaged Sealed docking bays or alternative in place to provide

equivalent level of protection? Suitable overhead rail system for red meat carcases,

sides and wholesale cuts? Store rooms and transit corridors finished to exposed

meat standards? Adequate separation between different exposed

meats?

3.Traceability

Adequate management and recording systems to enableproduct to be identified and associated with all relevant

documentation? Are adequate records maintained of incoming and

outgoing meat? Stored meat identifiable to origin? Good traceability of goods despatched? Does occupier ensure goods despatched from

premises are accompanied by appropriatedocumentation?

Good traceability of incoming meat, is it accompaniedby appropriate documentation?



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Annex 2

3

Co-located Cold Store Aide Memoire, Continued

4. Additionalissues (if

applicable)

Application of GHP together with the

implementation of HACCP based procedures whichincludes the cold store operation?

Health marking, wrapping and packagingrequirements observed w here resealing, re-liddingor re-boxing? All operations involved interference with packaging

carried out with knowledge of OV? Done hygienically?

All meat despatched checked for temperature &marking? Exposed meat checked for contamination? Packaged meat integrity of packaging checked? Loaded hygienically onto suitable transport vehicle?

action taken & recorded where not?

Incoming meat inspected for contamination,damage to packaging, compliance w ithtemperature, marking & documentationrequirements? action taken & recorded where

not?

Adequate system for returned product?

Adequate system for disposal of rejected product?

Imported beef checked? IMP 8/2 completed? IMP 8/1 completed when required?

Imported meat (EU/ Third country imports) Consignments accompanied by appropriate

documentation/CVED? Unsatisfactory consignments, follow up action?

In House Cold storage of carcases and offal w ith alocalised Cyticercus Bovis infestation is coldtreatment as ind icated in Chapter 2.4 Section 4?

In House Cold treatment of pig meat as analternative to Trichinella testing is cold treatmentas indicated in Chapter 2.4 Section 4?


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MHS Manual for Official ControlsChapter 4, Part 2: HACCP Based Procedures

Overview i

Part 2 - HACCP Based Procedures

Part 2 Overview

In this part The table below lists the sections in this Part.

Section SeePage

Section 1 - Introduction 1-1Section 2 Common Issues for HACCP Auditing 2-1Section 3 Microbiological Criteria 3-1

Section 4 Audit and Enforcement 4-1


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Section 1

Introduction 1-1

Section 1 - Introduction

Section Overview

In thissection


TopicSee

Page

Legislation 1-2Characteristics of HACCP Based Procedures 1-5


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Section 1

Introduction 1-2

Legislation

HACCP

legislativeframework

The following table summaries the different pieces of

legislation that cover FBO and OV responsibilities in relationto HACCP based procedures.

Regulation IssueWho is

responsible?Other documents

Ch II,Article5

Put in place, implementand maintain apermanent procedurebased on HACCPprinciples

FBO

CommissionGuidance

MIG

Food SafetyManagement

Diary for MeatProducers

Reg(EC)852/2004

AnnexII,Ch XII

Train staff responsible forthe development andmaintenance of HACCPbased procedures in theapplication of HACCPprinciples

FBO Commission

Guidance

MIG

Reg(EC)

853/2004

AnnexII,

SectionII

List of HACCP basedobjectives for incoming

animals accepted forslaughter

FBO

Commission

Guidance MIG

Reg(EC)854/2004

Ch II,Article4

Audit and verification thatFBOs apply HACCPprinciples continuouslyand properly OV

MOC

MIG

Food SafetyManagementDiary for MeatProducers

(EC)852/ 2004evidence

The FBO shall provide the OV with evidence of theircompliance with the HACCP legal requirements, taking intoaccount the nature and size of the business, and ensure thatany documents describing the procedures are up to date atall times.



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Section 1

Introduction 1-3

Legislation, Continued

(EC)852/ 2004

evidence,(continued)

The instructions in this chapter reflect the minimumrequirements expected to consider an FBO plan of HACCP-based procedures adequate and in compliance with theRegulations.

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

(EC)854/ 2004

OVverification

of HACCP

basedprocedures

The OV is required to conduct audits to verify that foodbusiness operators apply HACCP based procedurescontinuously and properly to make sure, in particular, that:

procedures guarantee that the requirements for incominganimals are met

meat complies with the microbiological criteria

meat complies with the community legislation onresidues, contaminants and prohibited substances

meat does not contain physical hazards, such as foreignbodies

Regulation: (EC) 854/2004, Chapter II, Article 4, 5.

Keyreferencedocuments

The Meat Industry Guide (MIG) contains information for FBOson the application of HACCP based principles to comply withthe legal requirements as well as advice. It takes account ofthe Commissions guidance on flexibility and includes genericHACCP plan material. It should be read by OVs advisingon or auditing the application of HACCP principles.

The European Commission has produced a guidancedocument for the implementation of procedures based on

HACCP principles and to facilitate the implementation ofHACCP principles in certain food businesses.

Reference: MOC, Volume 2 Legislation for additionalinformation.



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Section 1

Introduction 1-4

Legislation, Continued

Keyreference

documents,(continued)

The Food Safety Management Diary for Meat Producers (theDiary) has been produced by the FSA for smaller operators.The Diary is specifically designed to facilitate FBOs to keeprecords relating to the hygienic operation of their businesses.It also includes draft documentation on prerequisites andHACCP.

The use of the Diary by FBOs is voluntary.

Reference: See the topic Principle 7 Documentation inSection 2 of this chapter for additional information.


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Section 1

Introduction 1-5

Characteristics of HACCP Based P rocedures

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

HACCP is a set of 7 principles used to assess hazards andestablish control systems that focus on prevention ofproblems rather than relying solely on end-product testing.

Implemen-tation

requirements

The successful application of HACCP based proceduresrequires 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 theinvolvement of the work force.

TraditionalHACCP vs.HACCP based

procedures

Traditional, classic or technical HACCP is not the same asHACCP based procedures.

Traditional HACCP evolved from spacecraft manufacture to

guarantee the safety of astronauts food. It remainsappropriate for industrial production of processed foodstuffsinvolving for example, sterilisation or pasteurisation steps.

It is however acknowledged in (EC) 852/2004 and particularlyin the Commissions guidance on HACCP that such a technicalapproach may not be appropriate for all types and sizes offood businesses. In the case of meat plants, for example, itcan be sufficient to apply the principles in a more flexible wayfollowing guides to practice.



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Section 1

Introduction 1-6

Characteristics of HACCP Based P rocedures,Continued

Flexibility:Nature andsize of theoperations

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

the nature of the operations

the size of the business

Flexibilitytaking intoaccount

Comments

Nature of the

operations

In businesses handling food with no

significant food safety hazards (e.g.greengrocers) a hazard analysisconfirming that is the case can besufficient.

In businesses handling many foods (e.g.restaurants) a simplified approach usinga diary can be sufficient.

In businesses involving simple

processing (e.g. slaughterhouses andcutting plants) a generic plan with adiary for record keeping can be sufficientas long as they are adapted to reflectcompany conditions.

In food manufacturing businesses,particularly with procedures that willeliminate hazards (e.g. canning plants)full technical HACCP is moreappropriate.

OV auditors should consider whether theHACCP based procedures areappropriate for the type of business.



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Section 1

Introduct

Manual Control-Oficial Audit Engl

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