Chapter 4.1 Audit

Sections

1. Introduction

2. Legislation

3. FBO Responsibility

4. FSA Role

5. Risk Assessment

6. Annexes

1. Introduction

In this section

1.1 Definitions

1.2 Purpose of audits

1.3 Relationship between audit visits and OV attendance

1.4 Commencement of FBO audits following approval or periods of closure

1.1 Definitions

The following definitions apply for the purpose of this chapter.

1.1.1 OV presence

OVs are present in slaughterhouses and at the Smithfield Market to carry out inspection tasks every operational day.

Daily OV presence is not required for co-located cutting establishments and other establishments such as for standalone cutting plants and game handling establishments (GHE). However, co-located establishments operating at times coinciding with the slaughterhouse operational hours are under the supervision of the resident OV. Issues identified during the visits to the co-located cutting plant should be entered in the Chronos system and enforced under the standard enforcement principles. Deficiencies identified during these visits will be taken into account during the overall site audit.

Co-located establishments operating at times different from the slaughterhouse operational hours should be subjected to unannounced inspections (UAIs) same as stand-alone cutting plants. These establishments have already been included in the K2 system at the request of the FVC and a UAI visit request is automatically generated as if these were stand-alone cutting plants. If considered necessary, the inspector carrying out a UAI can also request the production of a UAI report for any co-located establishment to the K2 manager through the FVC.

1.1.2 Official visit

Official visits to any establishment (regardless of OV presence in slaughterhouses for carrying out inspection tasks), may be conducted for the purpose of carrying out a full audit, partial audit and/or a UAI.

1.1.3 Full audit

A full audit is an assessment of the FBO Food Safety Management Systems (FSMS). All listed approved FBO activities must be audited (within one day, or several days depending of complexity of the establishments considering several processes and operations).

1.1.4 Partial audit

Following a full audit, a partial audit will focus on specific themes identified as being non-compliant during the full audit.
Partial audits may be carried out on-site or remotely. See more details on remote audits in section 4.9.

1.1.5 Unannounced inspection

In addition to partial audits, and as part of the scheduled audit programme (see audit outcome and frequency of visits), UAI can take place to follow up specific issues identified during the audits or to verify continued compliance between audits.

1.2 Purpose of audits

1.2.1 Relevant premises

These audit arrangements apply to all meat establishments approved in England and Wales and under veterinary control.

These are:

• red meat / farmed game slaughterhouses
• poultry meat slaughterhouses
• cutting plants 
• game establishments
• minced meat, meat preparations and mechanically separated meat establishments co-located with slaughterhouses or cutting plants
• meat product plants and ‘ready to eat’ establishments co-located with slaughterhouses and cutting plants
• co-located cold stores

1.2.2 Risk assessment scheme

The audit risk assessment scheme applies the requirement of retained EU laws (REUL) 2019/627 Article 4 to determine the frequency of audit using the risk 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 past record of compliance with food law

Note: Risks associated with the throughput and type of process are not specifically listed in the AUD 9-3, but have been incorporated in the body of the audit report document.

1.2.3 Aim of audits

The aim of the FBO audit is to verify compliance with the legal requirements and to ensure adequate FBOs standards in relation to public health, animal health and welfare.

The audit sections in the audit report are based on the priorities set for the FSA that have been agreed between the FSA, Defra and industry stakeholders.

Audit findings should provide individual FBOs as well as the relevant competent authority (FSA and Local Authorities) with information on Non-Compliances (NCs) identified against regulatory requirements, and/or areas in need of correction or improvement. For the competent authority (CA), this may result in the review of the MOC or the development of new guidance, procedures and training.

1.2.4 ‘Effective’ audit

An effective audit of FBOs obligations in respect of public health, animal health and welfare is defined as follows:

• complies with the requirements of REUL 2019/627 to determine the frequency of audit on the basis of risk
• applies appropriate standards in determining the level of assurance that can be given to the CA about the FBO management procedures and identification of risk
• accurately assesses the FBOs level of compliance with legal requirements and identifies necessary enforcement actions
• recognises the FBOs good practices and identifies opportunities for improvement 
• communicates audit findings to the FBO and the CA 
• is consistent in its approach

1.2.5 Compliance audit and systems based audit

An effective audit of FBO controls will require the use of both ‘compliance audit’ and ‘systems based audit’ techniques, which are described below:

 

Audit technique	Description
Compliance audit	This is a review and examination of FBO records and activities to assess compliance with legislative requirements and the FBOs established policies and operational procedures. Much of the audit work to support compliance assessment will take place in the operational environment. In establishments where there is frequent OV presence, this assessment work will be ongoing as part of the FSA team’s normal duties between the production of audit reports.
Systems based audit	The auditor should seek to establish that the FBOs controls are fit for purpose and that the FBO has effective systems and processes in place to implement them on a continuous basis. Weaknesses and strengths in the FBOs control system should be recorded. Much of the audit work to support the systems assessment is likely to take place outside the operational environment.

1.2.6 Publication of FBO’s audit report

The Freedom of Information Act 2000 gave individuals a general right to information held by public authorities (subject to certain exemptions) and to have this information communicated to them. The Environmental Information Regulations 2004 also provides a right of public access to a range of environmental information held by public authorities.

Important note: Audit reports will be published for FSA approved meat establishments in England and Wales on the FSA website after the period for appeals has expired.

1.3 Relationship between audit visits and OV attendance

1.3.1 Overview

All audits of FSA approved establishments are to be carried out by Veterinary Auditors (VAs) or Audit Veterinary Leaders (AVLs), who are independent and separate from operations and routine inspection duties. 

The audit frequency represents the minimum number of times in a period that a completed audit report will be produced by a VA / AVL. This approach applies to slaughterhouses with or without a co-located cutting plant, game handling establishments, standalone cutting plants and cold stores under FSA supervision (for example, Smithfield Market).

Note: for simplification, further references to VAs / AVLs will be referred to as auditors unless specifically stated as VA or AVL.

1.3.2 Premises with frequent OV presence

OVs who work in a slaughterhouse approved for co-located operations may enter the production areas of other operations regardless of the audit timetable. However, the OV should consider the reasons for entry and ensure that it is part of their official control role. Daily checks in co-located operations are not required and the frequency of inspections should be determined based on risk assessment and third country export requirements. 

Reference: The Food Hygiene (Wales) Regulations 2006 (as amended), Regulation 14, 2 / The Food Safety and Hygiene (England) Regulations 2013 (as amended), Regulation 16, 2.

Co-located operations will be audited at the same time as the slaughterhouse, as part of the same process, with a single audit report being produced.

1.3.3 Premises with infrequent OV presence

Stand-alone cutting plants and any co-located operations will also be audited at the same time. In between audits or partial audits there may be UAIs.

1.4 Commencement of FBO audits following approval or periods of closure

1.4.1 Premises with specific requirements

The table below summarises the circumstances under which specific types of establishments operate under a different audit regime.

 

Establishment	Audit regime
All conditionally approved establishments (slaughterhouses, cutting plants and GHEs)	FBO audit by an auditor will not commence until full approval has been granted to the establishment following the FVL approval assessment(s). The OV / FVC may be requested to conduct monitoring and enforcement visits during the period of conditional approval; this will be at the specific request of the FVL. Where full approval has been granted, the first audit will take place in 3 months, from the date of full approval. The first UAI will take place during the first 3 months, from the date of full approval.
Existing premises: on change of FBO	A change of FBO marks the end of an existing establishment’s approval. The new FBO is required to make an application for a new approval. FBO audit by auditors will not commence until full approval has been granted following the FVL approval assessment(s). If during an audit it is identified that the legal entity has changed and a new approval is required, the audit must be stopped and the approvals team informed. The OV / FVC may be requested to conduct monitoring and enforcement visits during the period of conditional approval; this will be at the specific request of the FVC / FVL respectively. Where full approval has been granted, the first audit will take place in 3 months, from the date of full approval.
Existing premises with full approval- on application to extend or vary activities	In these circumstances, the FBO audit should continue as already scheduled for the fully approved activity. The additional activity will only need to be audited once full approval for that activity has been granted and following the FVL’s approval assessment. Any revision to the audit frequency, made necessary by the additional activity, will be established at the next regular scheduled audit after full approval is granted. For example: where a fully approved slaughterhouse has applied for additional approval as a cutting plant, audit of the slaughterhouse should continue as scheduled. The audit will include the cutting operations once full approval for that additional activity has been achieved.  where a fully approved cutting plant has applied for additional approval to add minced meat operations, audit of the cutting plant should continue as scheduled, but the minced meat operations should not be included in the audit until full approval for that activity has been granted. Once the next scheduled audit takes place after full approval of the minced meat operation, all approved activities will be audited, and the future audit frequency will be set based on the risks posed by all approved activities.
Seasonal closure* and temporary or long-term closures *Seasonal closures are pre-notified routine breaks in operation, to a seasonal pattern	Following a period of closure, the FBO is required to notify FSA at least 2 weeks prior to re-commencing operations. The FBO must not re-commence operations until a pre-opening FSA visit has been conducted. Note: Periods of closure are defined at paragraph 112 in the ‘Operational policy for the approval of meat establishments undertaken by the FSA’.  Where the outcome of the pre-opening visit confirms that the establishment meets all legislative requirements, the next FBO audit by the auditor should be completed no later than 2 months from operations re-commencing.
Premises under recommendation to suspend/withdraw approval	Audit activity is to be discontinued after a recommendation has been submitted by the FVL. Once the outcome has been decided, the audit cycle will be reinitiated with a full audit after 3 months. This audit will still take into account any minor non-compliance that remained open in the last audit, and that has not been part of the formal approval review. Note: The auditor would need to check with the FVL / AVL / Approvals team the relevant information from the review process as part of the audit preparation.

2. Legislation

In this section

2.1 Requirement for audit

2.1 Requirement for audit 

2.1.1 General requirements for official controls

It is a principle of REUL 2017/625 and 2019/627 that official controls will verify the FBOs compliance with REUL 852/2004, 853/2004 and other REUL and national regulations that apply to approved meat establishments.

Part of that verification process is the audit of good hygiene practices and HACCP-based procedures as required by REUL 852/2004 Article 5 and REUL 853/2004 Annex II, Section II, the FBOs food safety management system. 

In addition to the audit of good hygiene practice, the auditor must verify the FBOs continuous compliance with their own procedures for, amongst others, all aspects of animal by-product (ABP) handling (including SRM control), animal identification and animal health and welfare.

In addition to the audit of HACCP-based procedures the auditor must check that the operator’s procedures guarantee, to the extent possible, that meat is free from patho-physiological abnormalities, faecal or other contamination and SRM (subject to Community rules). 

Reference: REUL 2017/625, Article 18 and REUL 2019/627, Article 3

2.1.2 Food fraud

The recommendation of the Food Fraud Task Report 2007 is that auditors and other officials visiting food premises should bear in mind the possibility of fraudulent activities.

2.1.3 GHP audit

Audits of good hygiene practices shall verify that FBOs apply procedures continuously and properly. A detailed list of pre-requisites to consider can be found in sub topic 3.2.2 on ‘HACCP and pre-requisites’ in Part 1.

Reference: REUL 2019/627, Article 3,1

2.1.4 HACCP audit

Audits of HACCP-based procedures are to verify that FBOs are applying procedures continuously and properly. The auditor must determine whether the procedures guarantee, to the extent possible, that products of animal origin:

• comply with microbiological criteria laid down under EU legislation
• comply with Retained EU legislation on residues, contaminants and prohibited substances
• do not contain physical hazards, such as foreign bodies

Reference: REUL 2019/627, Article 3, 2 and 3

Where a food business operator takes additional measures to guarantee food safety by implementing integrated systems, private control systems or independent third-party certification, or by other means, and where these measures are documented and animals covered by such schemes are clearly identifiable, the competent authorities may take such measures into account when carrying out audits to review good hygiene practices and the HACCP-based procedures. 

Reference: REUL 2019/627, Article 4,2.

3. FBO Responsibility

In this section

3.1 Compliance with the legislation

3.2 HACCP based systems

3.1 Compliance with the legislation

3.1.1 FBO standards

The FBO is required to comply with the requirements of REUL 852/2004, 853/2004 other REUL and national regulations that apply to approved meat establishments. These are the standards against which the auditor will assess the FBO performance at audit.

Food safety management systems must be implemented and must be sufficient to achieve the objectives of the Regulations.

3.1.2 Access, records and assistance

The FBO is required to offer all assistance needed to ensure that official controls carried out by the Competent Authority can be performed effectively, and in particular to:

• give access to all buildings, premises, installations or other infrastructures
• make available any documentation and records required under the Regulations or considered necessary for judging the situation.

Reference: Retained (EU) legislation 2017/625, Article 15, The Food Hygiene (Wales) Regulations 2006 (as amended) / The Food Safety and Hygiene (England) Regulations 2013 (as amended).

3.2 HACCP based systems

3.2.1 Obligation to implement

The FBO, considering the nature and size of the business, has a duty to implement a permanent procedure based on the 7 HACCP principles of:

1. identifying any hazards that must be prevented, eliminated or reduced to acceptable levels
2. identifying the critical control points (CCPs) / control points required by regulations at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels
3. establishing critical limits / legal limits at CCPs / control points required by regulations which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards
4. establishing and implementing effective monitoring procedures at CCPs / control points required by regulations 
5. establishing corrective actions when monitoring indicates that a CCP / control point required by regulation is not under control
6. establishing procedures, which shall be carried out regularly, to verify that the measures outlined above are working effectively
7. establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined above

When any modification is made in the product, process, or any step, FBOs shall review the procedure and make the necessary changes to it.

The FBO must also provide the CA with evidence of their compliance and ensure that any documents describing the procedures are up-to-date at all times.

Reference: Retained (EC) legislation 852/2004, Article 5 

Reference: See MOC Volume 2, 14f on EU guidance document on the implementation of procedures based on HACCP principles, and on the facilitation of the implementation of the HACCP principles in certain food businesses;

3.2.2 HACCP and pre-requisites

HACCP systems are not a replacement for other food hygiene requirements, but a part of a package of food hygiene measures that must ensure safe food. It must be borne in mind that ‘prerequisite’ food hygiene requirements must be in place prior to establishing HACCP procedures, including in particular:

• checks on food chain information (FCI)
• the design, layout 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, any accompanying documentation

These requirements are designed to control hazards in a general way and they are clearly prescribed in Community law. They may be supplemented with guides to good practices established by the different food sectors.

Reference: EU guidance document on the implementation of procedures based on HACCP principles, and on the facilitation of the implementation of the HACCP principles in certain food businesses.

Note: Other requirements of Community law, such as traceability, the withdrawal of food and the duty of informing the CAs should, although not covered under the food hygiene rules, also be considered as prerequisite requirements.

Reference: Retained (EC) legislation 178/2002, Articles 18 and19.

4. FSA Role

In this section

4.1 Responsibilities

4.2 Audit schedule

4.3 Audit protocol

4.4 Completing the audit report

4.5 Audit assessment

4.6 Actions following audit

4.7 Unannounced inspection (UAI)

4.8 Enforcement

4.9 Remote Auditing

4.1 Responsibilities

4.1.1 Who conducts the audit?

Specially trained and experienced veterinary auditors will conduct audits at all approved meat establishments under FSA responsibility.

Note: OVs and novice OVs (NOV) do not undertake audit work but will provide supporting evidence for the audit. All relevant evidence gathered by them during the audit period must be available for the auditor (including the up to date ‘Enforcement Programme’ available in Chronos). 

4.1.2 Audit tasks

The following table identifies the different tasks and responsibility for completion.

Task	Timescale	Responsibility
Arrange audit visit date with FBO or their representative	Based on risk rate frequency for the month the audit is due; best practice is a minimum of 2 weeks before audit is due	Auditor
Confirm audit visit date in writing/ e-mail	Via K2, shortly after arranging visit	Auditor
Audit preparation gathering information on FBOs food safety management systems	-	Auditor
Gather information on food safety management systems	-	MHI / OV / NOV
Carry out audit visit: Opening meeting Inspection of the establishment and collection of evidence Documentary audit and collection of evidence creating audit notes Closing meeting Discussion of audit findings and final outcome (SH and GHE) Discussion of audit findings, final outcome and possible corrective actions, with the FBO or their representative (Stand Alone Cutting Plants (SACPs))	Depending on the complexity of the establishment, the auditor should consider allocating one or more audit days.	Auditor
Compile audit report and submit in K2	Within 5 working days after the visit	Auditor
Audit report authorisation in K2	Within 10 days of the audit visit	-
Distribute completed audit report to FBO, with copies provided to relevant FSA officials as required	-	Auditor or AVL Generated automatically by K2

4.1.3 Auditor’s code of ethics

The following four principles are the standards of conduct that are expected from auditor carrying out FBO audits:

1. Integrity 
   • Auditors shall demonstrate integrity in all aspects of their work. The relationship with OVs, MHIs and with FBOs should be one of honesty and fairness. This establishes an environment of trust which provides the basis for all activities carried out by the auditor.
2. Objectivity 
   • Auditors shall display professional objectivity when providing their opinions, assessments and recommendations. The auditor should not be unduly influenced by the views of others or by personal interest.
3. Competency
   • The auditor shall not carry out audits if they feel they do not have the base auditor competency or if they lack technical competency in the area being assessed. All auditors are to hold Food Safety Lead Auditor and Intermediate level HACCP qualifications. 
4. Confidentiality
   • Auditors shall safeguard the information they obtain while carrying out their duties. There should not be any unauthorised disclosure of information unless there is a legal or professional requirement to do so.

4.1.4 Auditor duties

The auditor is responsible for:

• arranging the audit visit with the FBO
• completing the audit within the calendar month of the designated audit frequency 
• auditing the FBOs FSMS and FBOs compliance with animal health and welfare Regulations
• completing the Audit report (AUD 9-3) 
• determining an audit outcome and audit frequency
• advising the FBO on compliance with legal requirements in relation to the audit
• (in stand-alone establishments) agreeing any necessary remedial action and timescales with the FBO, ensuring deficiencies are effectively addressed liaising with the UAI team as required, and escalation of any necessary enforcement activity as a result of the visit.

4.1.5 Auditor exclusions

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 FSA
• write company procedures or HACCP plans, although advice may be given
• provide the FBO with a copy of the un-checked audit report

4.1.6 Assurance measures: AVL duties

As an assurance measure, AVLs will carry out quality checks on a representative sample of issued audits within their areas (initially 10%). Those checks should include audits of poor performing plants (assessed as Improvement necessary and Urgent Improvement Necessary).

The AVL will also be responsible for profiling the audits in their area and ensuring targets are met.

4.1.7 Field staff duties

Field staff working regularly in an establishment must ensure that they are familiar with the procedures and systems put in place by the FBO, in particular for the processes for which they have an inspection role.

Note: The OV must ensure that MHIs working under their technical responsibility maintain a current understanding of the FBOs procedures and systems.

4.1.8 Automated system actions

The K2 system will:

• monitor the scheduling of the audit visits in accordance with the minimum audit frequency determined by the audit category
• monitor the timely production of audit reports
• distribute the completed report to the FBO
• maintain audit records

4.2 Audit schedule

4.2.1 Arranging visits

The auditor will contact the FBO, where possible, one month in advance of the audit being due (two weeks’ notice is acceptable but not best practice) to agree a date for the audit visit.

FBO audits should be arranged whilst the establishment is in operation and product being processed. If necessary, an audit may take place over a number of days of a week in order that as many processes as possible are audited. Where the establishment is not operational the audit may be delayed until the establishment is in operation with the agreement of the auditor.

The scheduling of the audit visits will be monitored in order to ensure that audit targets and frequencies are met.

The agreed date of the audit visit must be confirmed in writing to the FBO. This letter will provide the FBO with prior warning of an audit; outlining the scope of the audit and the access and information that will be required.

Notification of the audit will allow the FBO to make themselves, or the relevant members of their management team, available. In addition, it allows the FBO to have any necessary documentation available for audit.

Note: Where applicable (for example, seasonal operations), in order to confirm that the establishment is truly not operational, a regular programme of unannounced inspections should be set up until the audit takes place. 

Reference: See sub-topic 4.7.6 on ‘Unannounced inspection’ in part 1 for additional information.

4.2.2 Target for subsequent audit completion

Subsequent audit visits will be within the month determined by the last audit category.

4.2.3 Alternative arrangements

Where an audit date has been scheduled with the FBO and the FBO needs to cancel / rearrange, the auditor shall reschedule the audit working collaboratively with the FBO to agree a mutually agreeable date and time, updating K2 accordingly with the current agreed date and the reason for the cancellation.

However, cancelling audits at short notice creates a considerable problem to the FSA in terms of wasted hours and a knock-on effect to the number of FSA audits and workload of FSA auditors accumulating into proceeding months. This situation can incur a cost to the agency due to auditors wasted time preparing and travelling to audits which are subsequently cancelled.

The VA should notify the AVL of the problems in arranging the audit. At the discretion of the AVL, a letter can be sent to make the FBO aware of the impact and the potential implication cancelations at short notice have on the audit system. The FBO audit cancellation letter template (Annex 5) can be tailored to the different scenarios that may occur. 

4.3 Audit protocol

4.3.1 Collecting evidence as to the compliance of the FBO

In slaughterhouses: FSA staff are present every day the plant operates. As part of day to day business they should record objective evidence as to the level of compliance by the FBO with both his own procedures and with legislative requirements.

In cutting plants: FSA staff will normally only be present to conduct the audit, although the premises should have been the subject of UAIs in the period since the last audit. Prior to a scheduled audit taking place, the auditor should establish whether any UAIs have taken place and if so, what enforcement activity arose as a result.

Both the OV and MHI have an important role to play in identifying and recording NCs. Objective evidence of NC issues may be recorded:

• on the relevant operational form
• in the daybook
• in the enforcement programme (Chronos)

Note: ‘Major’ or ‘critical’ NCs should trigger an immediate action.

4.3.2 Assessment of operational records

Prior to the audit, the auditor must review enforcement records for the period since the last audit and use this information when assessing the effectiveness of the FBOs food safety management procedures and HACCP based system, taking account of corrective actions. For the purpose of the assessment, the auditor might request and review other records they find relevant, including hygiene, welfare, ABPs forms and UAI reports.

Auditors can obtain additional information about the level of FBO’s compliance in an establishment through contact with the local FSA team (MHIs, OVs, FVC and FVLs). 

Reference: See sub-topic 5.2.1 on ‘FBO compliance history’ in part 1 for additional information.

4.3.3 The opening meeting

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

• reason for and scope of the audit, anticipated length of the audit and the day programme
• information and access that will be required
• purpose of the subsequent closing meeting
• publication of audit categories

The opening meeting should also be used to:

• confirm that there are no changes to FBO, structures, equipment or activities since the last audit and that all necessary approvals are in place
• highlight that if during an audit it is identified that there has been a change of legal entity, the audit will be stopped, and the approvals team informed; a new approval is required
• review of the Non-compliance Report (NCR) from the last audit
• highlight any issue identified from the audit preparation review of operational forms.

4.3.4 When carrying out the audit

During the audit, the auditor will:

• collect and record objective evidence of the FBOs compliance with legislative requirements for food safety management systems based on HACCP principles, including ABP and where appropriate, SRM, animal health and welfare procedures 
• inspect the establishment (‘reality checks’) to observe whether the FBO’s procedures in practice reflect the policies and procedures as documented

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

• score individual questions and sections as compliant or non-compliant (minor, major, critical)
• determine the overall audit outcome as Good, Generally Satisfactory, Improvement Necessary and Urgent Improvement Necessary

4.3.5 Serious issues identified during audit

If an issue of serious public health, animal health or welfare arises during an audit (for example, considered ‘critical’), the auditor should:

• inform the FBO, the OV (where appropriate) immediately, and the FVL / FVC as soon as possible 
• take / instruct the OV for any necessary enforcement action to be taken
• consider curtailing the current audit

4.3.6 Reference to previous audit reports

During subsequent audits, the auditor should refer to the previous Audit Report to direct priorities during audit in a risk based manner. The auditor should put special attention on areas where major or critical NCs were identified. Those will always have to be reassessed in the next audit.

4.3.7 Audit notes

It is important that audit notes are taken during the audit as they constitute an essential element to support the auditor audit findings and justify the audit assessments.

Auditors can use the audit checklist (Annex 3) to record evidence. 

Each page should include:

• have the audit number which comprises the four-digit approval number, site type and audit date (month/year), that is xxxx-SH-mm/yy
• contain contemporaneous, detailed and legible notes which are cross-referenced to the aide memoire reference notes of the AUD 9/3 form
• date and signature of the auditor

Audit notes do not need to be submitted with the audit report but they should be retained and made readily available for next audit or as and when requested.

Audit notes must be retained for a minimum of 2 years (more than 2 years if there are ongoing outstanding enforcement actions).

Updated [Audit notes should not substitute the use of contemporaneous notebook for recording enforcement evidence admissible to court if the occasion arises].

4.3.8 FBO involvement in audit

The auditor should expect to be accompanied by the FBO (or a nominated representative) during the visit.

4.3.9 The closing meeting

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

• summarise the audit findings (positive and negative)
• outline any NCs
• discuss the corrective action required, including any proposed timescales and possible enforcement action for Stand Alone Cutting Plants (SACPs)
• give an indication of the expected audit category
• give details of report procedure
• give details of publication of the audit categories
• outline subsequent action and right of appeal

The closing meeting provides an opportunity for the FBO to respond to audit findings, to discuss his proposed actions and to provide any further supporting evidence if he disagrees with any audit findings.

The resident OV in slaughterhouses, co-located cutting plants and GHE shall attend the closing meeting, whenever possible.

4.3.10 Further information provided by the FBO

The FBO may provide additional evidence following discussions at the closing meeting. Provided this evidence is received by the auditor within 5 working days of the audit, it may be taken into consideration.

4.3.11 Audit report

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

The completed report should be submitted by the auditor within 5 working days of the audit visit.

Reference: See topic 4.4 on ‘Completing the Audit Report’ in part 1 for additional information.

4.3.12 Submission of Audit report (AUD 9/3)

The following table details the process which should be followed after completion of the audit report.

 

Step	Action
1	The auditor completes and submits audit report within 10 working days.
2	K2 automatically records the audit report
3	K2 distributes the completed audit report to the FBO, Service Delivery Partner (SDP) and to other parties if required for assurance checks.

4.3.13 Auditor’s feedback to the FSA team

The SDP receives a copy of the completed audit report sent to FBO. The resident OV is responsible for making all members of the team aware of the audit results, including NCs, the corrective action and timescales.

Note: Any FSA performance issues identified during an audit must be reported using the K2 system.

4.4 Completing the Audit Report

4.4.1 Use of objective evidence

As the formal record of the audit findings, the audit report must contain objective evidence to support the overall findings of the audit and the results given to the FBO during the closing meeting of the audit visit.

Although it was agreed with industry stakeholders that the audit report will mostly contain exception reporting, good audit practice dictates that reports should include both positive and negative reporting. The trigger for the auditor to make narrative entries in the supporting evidence box will be based on the score in the assessment box. Assessment boxes which have not been marked as ‘compliant’, or changing scores from the previous baseline audit will require an entry in the supporting evidence box.

Note: The audit writing guidance document (Annex 2) has been developed to assist auditors with aspects of report writing. It includes tips on style, accuracy, consistency and objectivity. 

4.4.2 Use of positive language

The auditor should use positive language during the closing meeting and in the audit report.

This will help to promote constructive communication of audit findings between the auditor and the FBO, better participation and resolution of NCs through joint identification of action and opportunities for improvement, which is the main aim of the audit.

4.5 Audit assessment

4.5.1 Recording compliance

Each question of the audit report requires the auditor to gather evidence regarding the level of compliance with the stated outcomes and record it as compliant minor, major, or critical NC.

Note: Only one NC is to be recorded for each question; this is to be especially considered when using the link tool explained in 4.6.5.

4.6 Actions following the audit

Note: For the purposes of this section, the following definitions apply:

• deficiency – an individual and very specific failure to comply with the legislative requirements (for example, in-rolling, dirty surface, uncut bird(s)) which are entered individually in the enforcement programme and are used as supporting evidence to justify audit NCs
• NC – a failure to comply with legislative requirements against a question and which is supported by one or several related deficiencies
• question – each sentence intended to elicit information in the audit report and which is assessed depending on the level of compliance
• section – a group of questions in the audit report under the same general heading

4.6.1 Audit outcome

The approach following the audit will depend on the outcome of the audit and the number of identified minor, major and critical NCs.

In slaughterhouses, co-located cutting plants and wild game establishments the resident OV owns and is responsible for the amendment, completion and update in Chronos. When the incumbent OV is not present at any stage of the audit, the auditor will ensure that the deficiencies are effectively communicated to the plant lead OV so that they can update the Chronos system and follow up on the enforcement.

For stand-alone cutting establishments, the responsibility is shared; this means the auditor will take any necessary enforcement action and record it in Chronos, but then the responsibility will be transferred to the field team.

4.6.2 Request to change the auditing frequency / early audit

Audit frequencies can be re-assessed at the request of FSA and/or the FBO.

On FBO formal request, the date of the audit may be brought forward under certain specific circumstances (for example, during busy periods, for commercial reasons or after a bad audit outcome).

However, an early audit should not be requested immediately after an unsatisfactory audit. In these circumstances scheduled audit frequency can be only changed if all major and critical NCs were signed off as complete and in the case of stand-alone cutting plants, an UAI has been completed as specified in the requirements. This should be assessed on a case by case basis. 

The FSA may also decide to carry out a full audit of an establishment prior to its scheduled date if serious deficiencies are identified. This can be requested by either the field or assurance FSA teams.

Field teams request: if falling standards on a particular establishment leads to the last audit outcome not reflecting the actual situation of the site, despite the progression of the enforcement and the approach through the Intervention Protocol. For example, establishment on extended audit frequency with sudden continuous increase in the level of enforcement.

Assurance team request; if after a partial audit the number of major or critical NCs increases to the extent of these exceeding the permitted numbers in the previous audit outcome.

In order to keep the separation between the audit and enforcement functions, an audit cannot be brought forward from its frequency unless the Auditor is satisfied that all appropriate enforcement is in place, as it is a basic principle of auditing that an audit should not be another enforcement tool.

Each proposal will be discussed on a case by case basis with the AVL and the Approvals and Veterinary Audit Lead with a decision being made on the evidence available to ensure a consistent approach.

Audits may only be postponed in exceptional circumstances, for example, if the establishment is not operational when the audit is due or other unforeseeable circumstances.

4.6.3 Minor NCs

Minor NCs are followed up by the resident OV in the case of slaughterhouses, co-located cutting plants and GHE or during UAIs in the case of stand-alone cutting plants. FVC / OV / MHI involved in the UAIs can assess the corrective action taken by the FBO on the deficiencies identified during the visits.

The minor NCs will be reassessed in the following partial/full audit by the auditor, based on the information provided by the field teams, and then the auditor will decide to either close it or maintain it open.

4.6.4 Critical and major NCs

Auditors will carry out partial audits of any establishment with critical and/or major NCs to assess progress towards compliance. These visits will be chargeable to the FBO and will be treated separately to the UAI programme.

• Critical NCs can only be closed off by the auditor following an on-site partial audit where compliance could be verified.
• Major NCs can be assessed without the need of a visit if the VA considers that sufficient evidence of compliance can be obtained remotely (from the FSA local team or FBO) to close this off where:
  • The auditor is satisfied that a major NC identified at the full audit (from the Chronos report) has already been effectively rectified by the FBO during the audit period, that major NC can be closed off at the time of audit reporting. No visit or partial audit report will be required.
  • The audit outcome is ‘generally satisfactory’, the auditor has the option to accept evidence provided by the FBO and corroborated by the resident OV or the UAI to close off a major NC. A visit is not essential, but a partial audit report is required. The auditors have the discretion to visit plant if they consider it necessary.

4.6.5 NC closed count to vs do not count to outcome

When a NC is closed, either at a full or partial audit, the auditor should decide if the closed NC will count towards the outcome of the audit or not:

• If the NC raised at a full audit is closed at the next full or partial audit and the deficiencies have been resolved within the agreed timescale and without the need to escalate enforcement, the auditor should mark it as closed – do not count to outcome. The NC will not appear in the next full audit report.
• If the NC is closed at the next full or partial audit but the agreed timescales to resolve the deficiencies have not been met and/or enforcement has required escalation, the auditor should mark it as closed – count to outcome. This will not appear automatically in the next full audit report and should be manually added in the following audit report. The auditor should decide the final assessment based on the evidence available during the audit period.
• If a NC raised at the full audit is closed at the full audit, it should always count to the outcome. This may be for matters that happened during the audited period (for example, raised by the OV on site or by the inspector during a UAI visit) but that had been correct at the time of the audit.

4.6.6 Use of the link tool

Linking of NCs should be done

• to prevent the same deficiency from being raised as different NCs in more than one question in the audit report.
  • If the auditor considers that there is a deficiency that constitutes a NC that applies to several questions, the auditor should use the link tool so that the same deficiency is recorded in all the applicable questions. This will count as a single NC for audit outcome purposes and all linked questions will have the same NC with the same score recorded against them in the NC report.

Examples:

• NCs relating to contamination / cross-contamination (section 3) might be linked to the FBOs food safety management system failure so consideration should be given to linking these to the relevant question in the HACCP section (section 5).
• NCs relating to inadequate welfare practices might be linked to the FBOs welfare management system failure so consideration should be given to linking these to other questions in section 2.

4.6.7 Contribution of minor NCs to the severity of Major NCs

If the use of the linking tool is not justified due to the same deficiency not affecting two different questions, the auditor can justify the increase in the severity of a question -scoring that question as a Major NC- based on the fact that deficiencies considered in other questions contribute to this assessment. 

The other questions to which the Major NC relates will be individually assessed/scored, through the auditor’s risk assessment, and the auditor can make a reference in the description of the relevant question, for example ‘this deficiency contributes to the assessment of Major in the NC raised in question X’ but without using the link facility. The contributing questions can have a different score from the one they are contributing to. 

4.7 Unannounced inspections (UAIs)

4.7.1 Background

Unannounced inspections (UAIs) support the audit process and ensure the FSA’s obligations are met through the verification of FBOs compliance with relevant legal requirements in FSA approved meat establishments where there is no regular official presence or in the case of co-located cutting plants, when the activities take place outside the statement of resources (SOR) hours.

Assimilated EU regulations require official controls to be carried out without prior notice to the FBOs, except where such notice is necessary and duly justified for the official control to be carried out, for example in the case of audits. The programme of unannounced inspections is an essential part of the delivery of official controls in support of the FSA audit programme. 

Official Veterinarians (OVs) and Official Auxiliaries (OAs) may undertake UAIs on stand-alone/co-located cutting plants under the direction of the relevant Field Veterinary Coordinator (FVC) for the area.

Aim of UAIs
The aim of the UAIs is to verify the FBO’s compliance with the legal requirements in relation to food safety and to ensure adequate FBOs standards in relation to public health.

UAIs verify FBO compliance between full audits and assess the FBO’s continued and effective application of legal requirements, food safety management systems and HACCP based procedures. UAI findings should provide individual FBOs as well as the relevant competent authorities (FSA and Local Authorities) with information on contraventions identified against regulatory requirements, and/or areas in need of correction or improvement. If contraventions are identified during an UAI, proportionate and risk-based enforcement action may need to be taken.

UAI tasks include, amongst others, the follow up on findings from previous audits and/or previous UAI visits. The contraventions identified during UAIs are considered part of the overall picture of FBO performance/compliance between full audits which have an impact on the final audit outcome for the audited period.

Programme of UAIs
The Field Veterinary Leaders (FVLs) are accountable for the UAI programme within their region. However, this is organised by the FVCs, with the support of the regional Lead Unannounced Inspector (LUAI). 

While standing alone cutting plants are always subject to UAIs, not all co-located cutting plants are. 

Approved cutting plants that are co-located to and operating at the same time as approved slaughterhouses where there is permanent OV presence will not be subject to UAI visits. However, if the co-located cutting premises operate only at different times to the slaughter operations when there is no OV presence, UAI visits must be scheduled accordingly.

If the co-located cutting plant operates both on slaughter and non-slaughter days, it will not be subject to UAIs as long as all the approved activities can be observed on the days when the OV is in attendance. However, if there are specific issues or concerns, UAI visits can be scheduled by the FVC on non-slaughter days.

The same principle is also applicable to approved cutting plants that are co-located to game handling establishments (GHE). When there is permanent OV presence at the GHE, the co-located cutting plant will not be subject to UAI visits. However, in the cases where the co-located cutting premises operates only at different times from the GHE, it will be subject to UAIs. Other specific scenarios will be considered by the relevant FVC. When there are issues or concerns, UAIs can be organised at the discretion of the FVC.

Please see Chapter 2.10, section 3, for details of inspections in co-located cutting plants that do not fall under the UAI regime.

For the cutting plants that are to be subjected to UAIs, the FVC allocates the minimum number of UAIs per establishment as indicated by the UAI scheduler in the UAI application, which is in line with the frequency of UAIs shown in the table below. Please refer to section 4.7.2 for details. In addition, the FVC carries out a risk assessment and evaluates the outcome of previous audits, unannounced inspections, any food incidents and/or complaints, and the enforcement activity at the premises. Following the review of this information and after carrying out a risk assessment, FVCs may decide to increase the number of UAIs at the establishment.

The UAIs are assigned by the FVC using the UAI application in the K2 system, taking into account the establishment location and staff resources available. The UAI application can be found at the following link: UAI application.   

The relevant Authorised Officers and their line managers are automatically informed by email when the UAIs have been scheduled to them. The schedule includes the date by which the UAIs are to be undertaken, allowing time for resources to be allocated. 

4.7.2 Frequency of UAI visits

All eligible cutting plants must receive at least one UAI during the period between full audits. After an UAI, the need for further UAIs may be identified and FVCs should utilise a risk-based approach when scheduling such inspections.

The following table shows the minimum frequency of UAIs required.

 

UAI visits required.">

Establishment	Frequency
Conditionally approved establishments (stand-alone and eligible co-located cutting plants)	UAIs will not commence until full approval has been granted to the establishment. Where full approval has been granted, the first UAI will take place during the first 3 months, from the date of full approval, and should occur before the first full audit.
Approved establishments (stand-alone and eligible co-located cutting plants)	A minimum of one UAI between full audits.  Please note that approved establishments receiving unannounced inspections can be subject to extended audit frequencies if two consecutive “good” audit outcomes are achieved, such premises will require additional UAI visits (minimum of 2 UAIs in the audit cycle) as described in section 5.3.3 (extended audit frequency).
Stand-alone and eligible co-located cutting plants that are approved for ready-to-eat (RTE).	A minimum of two UAIs between full audits. Please note that RTE approved establishments subjected to extended audit frequencies will require a minimum of 3 UAIs in the audit cycle.
Stand-alone and eligible co-located cutting plants where serious deficiencies have been identified during an audit or at a previous UAI.	It is appropriate to schedule additional UAIs as the FVC deems necessary. An UAI may also be scheduled prior to a partial audit to verify compliance on an unannounced basis.
Stand-alone and eligible co-located cutting plants where intelligence and/or food complaints are received relating to the approved premises.	It is appropriate to schedule a visit by an unannounced inspector or FVC to investigate such occurrences. These visits would not normally be classed as UAIs, but if new contraventions are identified during the visit, a UAI report should be completed, and the visit will be classed as a UAI.

Where UAIs identify serious contraventions related to food safety, the Authorised Officer conducting the UAI should inform the relevant FVC, who in turn will discuss it with the FVL, and together will assess if the meat establishment needs to be placed under the intervention protocol. A review of approval may be triggered, too. FBO audits may also be brought forward in certain circumstances and at the request of the field operations team. Each case is to be considered on its own merit.

The routine programme of inspections does not supersede review of approval protocols or emergency inspections following receipt of intelligence / food complaints.

Responsibilities

4.7.2.1 Who conducts the UAI?

Only OAs who have completed the UAI training and have passed a practical assessment by a FVC, and OVs, who are suitably trained/familiarised with the process, are assigned to undertake UAIs.

FSA employed unannounced inspectors are supported by a local FVC, a regional Lead Unannounced Inspector (LUAI), and their relevant Inspection Team Leaders (ITLs). Unannounced inspectors working for the Service Delivery Partner (SDP) shall be trained and supported through their normal managerial structure.

4.7.2.2 Tasks

4.7.2.2.1 Unannounced inspector duties

The unannounced inspector is responsible for:

• arranging the UAI visit with the ITL
• completing the UAI within the timescales indicated by the FVC
• inspecting the establishment to verify FBO’s compliance with legal requirements
• advising the FBO on compliance with legal requirements and agreeing any necessary corrective action and timescales with the FBO
• ensuring deficiencies are effectively addressed; liaising with the auditors’ team or the plant OV as required, and taking any necessary enforcement activity as a result of the visit
• completing the UAI report in the UAI app

The table below summarises the unannounced inspectors’ tasks and provide details of actions required and timescales.

 

FVC roles and responsibilities">

Tasks	Responsibilities and actions	Timescales
Organising visits	Liaise with ITL and FVC to ensure assigned visits are completed on time and in line with the scheduled request. Sufficient time must be planned to include preparation, visit, updating of enforcement, report writing time and other visit related admin tasks.	UAIs must be organised shortly after they have been  assigned.
Preparation for the UAI visit	Use the UAI Application to access the information required to prepare the visit.  Liaise with Veterinary Auditors (VAs), FVCs, LUAIs and plant OVs when applicable. Complete any formal notices that may need to be served and send them to FVC for accuracy check.	Prior to the UAI visit.
UAI visit	All UAI visits should be carried out in accordance with the FSA Health and Safety at Work Policy and Lone Worker Provisions.  Complete UAI in line with training and relevant guidance available on the UAI Application. Take proportionate enforcement if contraventions are identified. Collect evidence of contraventions identified (photos, videos, seize evidence…) and make notes in the contemporaneous notebook when needed.	To notify your manager of onsite arrival and departing during the UAI visit.
Report Submission	To use the UAI Application to write the report and update the enforcement programme. To ensure all reports are submitted timely, plant profiles are updated, enforcement programme is updated, and any photos/ evidence are stored in the plant folder of the Share-point.  Contraventions identified during UAIs need to be recorded in Chronos and enforced following the hierarchy of enforcement and in accordance with the FSA enforcement policy.  Chronos update is done automatically on completion of the UAI report.	Five working days to complete reports and any other task required. Reports are to be submitted to FBOs within ten working days of the UAI, allowing the extra five working days for the FVC checks, when needed. Written advice is to be completed,  and sent to the FVC,  within two working days of the UAI taking place.
Formal Notices	Complete formal notices and send them to FVC for accuracy check. This could be done before the visit, as part of preparation, if the unannounced inspector considers an issue is likely to escalate, or during the visit if necessary.  Whenever possible, to discuss the serving of a notice with the relevant FVC whilst at the premises.	Notices must be sent to the FVC for approval before serving, or if not achievable,  scans of notices must be sent to the FVC on the same day  they were handed and before posting.
Feedback	Reporting significant findings of UAIs back to the FVC.	After the visit.

4.7.2.2.2 FVC duties

UAI roles and responsibilities">

Tasks	Responsibilities and actions	Timescales
Schedule UAIs	Schedule UAIs, in line with the requirements described in section 4.7.3 using the UAI Application.	Frequency to be in line with the requirements described in 4.7.4 or as indicated by the scheduler in the UAI app.
UAI visits to establishments approved for RTE and/or other products of animal origin (OPAO)	Carry out UAIs at RTE and/or OPAO establishments or ensure they are timely assigned to: the SDP, so they can be completed by OVs. a LUAI in possession of the relevant training/qualification.	Frequency to be in line with the requirements explained in section 4.7.3 or as  indicated by the scheduler in the UAI App.
Technical advice	Support FSA employed unannounced inspectors with technical advice and knowledge where possible during the allocated UAIs from preparation of the visit to submission of the report. If the FVC is not available during the visit times, it should provide details of someone within the technical management chain available to take calls from the unannounced inspector should the need arise.	Before the visit, during or after if requested by the unannounced inspector.
Written advice	Check all written advice produced by Unannounced inspectors before postage to FBO	Written advice is to be checked  within three working days from receipt  of the letter.  Submission  to FBOs must be within five working days of the UAI visit.
Formal notices	Review all formal notices produced by unannounced inspectors before service. This work needs to be prioritised and completed without any delay. On the exceptional occasions when this is not achievable, for example when legal advice is required before serving a notice or liaison with the Veterinary Enforcement Delivery Managers (VEDMs) for opinion/ consistency is needed, the FVC will review the notice as soon as possible after it is handed out to the FBO and before posting.	During preparation, before the visit, if indicated by escalation in Chronos. Final check should be completed on the same day as the visit and before postage.
Accuracy and consistency checks.	Conduct checks on a representative sample of reports to improve UAI standards. Record the findings using the UAI development review form in line with the established internal framework.	In accordance with the internal framework.  Minimum, 1 report check per inspector per quarter, if inspector completes up to 10 UAIs, and 2 reports’ checks, if more than 10 UAIs are carried out per quarter.
Performance	Liaise with LUAI to obtain/pass feedback on the unannounced inspector's performance. Undertake one shadow visit per year with each FSA employed unannounced inspector working in the region, including the LUAI. Assess the inspector performance during the UAI visit and record it using the UAI development review form in line with the established internal framework.	Annually for each Inspector.

4.7.2.2.3 LUAI duties

UAI roles and responsibilities">

Tasks	Responsibilities and actions	Timescales
UAI visits	Carry out some UAIs in challenging establishments as requested by the FVC. Including UAIs at RTE and/or OPAO establishments if the relevant training/qualification has been obtained.	When requested by FVCs.
Delivery of the UAI programme	Work with FVCs to support co-ordination of UAIs across the region and explore improved ways of delivering them more effectively and efficiently. Promote and improve the delivery and quality of UAIs.	Regularly.
Support and guidance	Support and develop the skill sets of unannounced inspectors in their area of control, assessing the capability of UAI resource in the region including competence levels and identifying development needs. Organise regional meetings to provide guidance and ensure consistency within the unannounced inspectors team.	Ongoing.       Quarterly.
Performance	Liaise with FVC and ITLs to obtain/pass feedback on the unannounced inspector's performance. Undertake one shadow visit per year with each inspector working in the region. Record the findings using the development review form in line with the established internal framework.  Where appropriate LUAIs are to contribute to performance management meetings.	Annually for each inspector.
Review UAIs documentation/ software	Regularly review and where necessary update all documentation / software such as the UAI aide memoire and the UAI application, ensuring all are up to date and continual improvement.	Annually as a minimum.

4.7.2.3 Unannounced inspectors support and development

The LUAI acts as a coach and mentor to unannounced inspectors looking to continually improve the delivery and quality of UAI across the agency.

The LUAI will develop and review training materials, arrange practical and theoretical training and assess the competency of existing and new staff being deployed into the UAI role.

The LUAI will regularly undertake visits with all unannounced inspectors within his region to provide advice and support. They also act as a safety element in difficult UAIs, when more than one unannounced inspector is needed due to safety concerns.

4.7.2.4 Assurance measures 

As an assurance measure, FVCs will conduct quality checks on a representative sample of UAI reports within their areas. 

The FVC and LUAI will also be responsible for assessing the performance of the FSA employed unannounced inspectors by shadowing them during a visit to an establishment and completing a development review form each on an annual basis.

4.7.2.5 Automated system actions 

The UAI app will: 

• suggest the possible scheduling dates of the UAIs in accordance with the minimum UAI frequency. 
• displays the current status of scheduled UAIs. 
• provide all the links to the materials required to fully prepare a visit.
• store guidance documentation for unannounced inspectors.
• allow the timely production of UAI reports. 
• automatically distribute the completed reports to the FBOs when submitted.
• produce data on UAIs completed.

4.7.3 Conducting the UAI 

4.7.3.1 Pre-inspection preparation: 

Prior to carrying out any UAI to a cutting plant, the unannounced inspector must ensure that:
 

• They are clear on the scope of activities to be reviewed during the UAI. 
• Where appropriate, they have discussions with the Veterinary Auditor (VA), who conducted the last audit, and the OV responsible for the plant (when the cutting plant is co-located to an abattoir or GHE) prior to the UAI. This is to discuss areas of operation to be reviewed following the last audit findings, the enforcement programme, local requirements, and capture areas the auditing VA would like more focused attention.
• They also liaise with their FVCs should they need to discuss technical issues relating to the inspection visit. This includes when the preparation of enforcement notices could be required. The SDP staff conducting UAIs will follow their own processes under the arrangements of the fully managed service.
• The FVC, ITL, LUAI or SDP management, following their own internal arrangements, are aware of the day and time of the inspection and have contact details for any assistance required from those persons.
• They have all the required equipment and documentation with them, such as authorisations and FSA ID card, contemporaneous notebook, printed version of the UAI report form for the inspection (note: this can be accessed and printed from the UAI app), calibrated thermometer, camera or work phone, torch, blank notices, FSA detained tape, evidence bags, seals and any other equipment and information required for that visit. 
   

Please note this is not an exhaustive list. 

Guidance on how to prepare and complete an UAI is available on the UAI application under the “completing assigned UAI” tab.

During the preparation the following documents, which can be accessed through the UAI application, should be reviewed:

-    Previous UAIs
-    Previous FBO audits and the FBO audit calendar
-    View open and/or pending deficiencies in the enforcement programme accessing Chronos
-    Establishment information on E&P
-    Companies house information for legal entity and company status
-    Plant details in the SharePoint folder
-    Map of establishment location

4.7.3.2 The UAI

The unannounced inspector should carry out the inspection following the protocols established in the guidance and following any instructions provided by the FVC/LUAI, specific to the plant in question.

If, when undertaking an UAI, the unannounced inspector is refused access to the premises, they should contact the FVC (or the LUAI in their absence) immediately, to seek guidance and note the details in their contemporaneous notebook. The SDP staff should also notify their line management in these circumstances (see Chapter 7, Annex 21 Q&A on Obstruction, for further information).

The UAI should include the following stages:
1. Opening meeting
The unannounced inspector should have a brief meeting with the FBO, or FBO’s representative, at the beginning of the UAI, ensuring this does not cause unnecessary delays before commencing the inspection. The following details should be covered:

• inform of the purpose of the UAI
• explain charging arrangements
• confirm that there are no changes in the legal entity, process, or layout since the previous UAI/audit
• discuss pending deficiencies from the last audit/UAI(s) at the establishment
   

If the unannounced inspector has any concerns in relation to the establishment, they should prioritise the visit to the production areas and discuss the above details at a later stage. 

2. Inspection
The inspection is divided in two parts:

• Visit to the production areas

This is based on “reality checks”. The unannounced inspector observes all the operations being carried out in the production areas, assessing the hygiene of the operations and staff practices, temperature control, maintenance/cleaning of equipment and premises and handling and storage of animal by products. Please note this is not an exhaustive list.

Pending contraventions in Chronos are also assessed and verified. New findings (if identified) are further discussed with the FBO/FBO’s representative.

If an issue of serious public health arises during the course of the UAI, regardless of whether it is outside of the pre-defined scope of the inspection, immediate enforcement action, including gathering of evidence, must take place. The FVC / LUAI or the SPD internal management structure may provide advice to the unannounced inspector on the necessary enforcement action to be taken and appropriate evidence to be gathered. It is always good practice to obtain corroboration whenever possible. Please note that on these circumstances It may be appropriate to consider curtailing the inspection.

• Review of documentation

The unannounced inspector should review operational records, CCP monitoring records, and ABP commercial documents. Other records such as water results and pest controls records can also be reviewed. Any documentation related to pending deficiencies included in Chronos needs to be checked.

If there are new contraventions identified during the UAI, the unannounced inspector may consider what further documentation needs to be requested/assessed. 

3.  Closing meeting
The UAI must be concluded with a closing meeting with the FBO (or appropriate representative) in which the unannounced inspector will: 

• summarise the findings (positive and negative)
• discuss the corrective actions required, including any proposed timescales and enforcement action
• outline subsequent actions and the possibility for the FBO to provide supporting evidence after the inspection
   

At the end of the UAI, particularly in the cases when significant contraventions have been identified, the unannounced inspector will inform the FVC. The FVC will assess the findings, using a risk-based approach, to decide if any further visits may be required.

4.7.3.3 Completion and submission of the report 

Please follow the guidance on “completing an assigned UAI” available in the UAI application.
The UAI report is to be completed by exception reporting, which means, everything that has been checked during the UAI is compliant, if not highlighted in Chronos. The information entered in Chronos, is the only information that will appear in the body of the report, which is why it is important to describe any contraventions correctly, including the risks posed, any mitigating circumstances and if the risk was high, the corrective actions taken by the FBO to resolve the issue. 

In the cases where no contraventions are identified, the unannounced inspector will need to provide a brief explanation on the comments section of the report as per the guidance.
The report includes a Non-Compliance Report (NCR) identifying areas requiring corrective action and any corrective actions completed (in grey) from previous audits / inspections at the establishment. New corrective actions identified on the day of the inspection are shown in bold and marked as !NEW.

The UAI report must be compiled from the inspection findings and should not differ from the findings presented verbally to the FBO, or FBO representative, during the closing meeting. 
The completed report should be submitted by the unannounced inspector within five working days of the visit, and under no circumstances over ten working days from the UAI.

4.7.3.4 Enforcement

When completing the UAI report with the contraventions identified during the UAI visit, such contraventions will appear by default in Chronos with the deadlines agreed during the closing meeting with FBO/FBO’s representative. If contraventions are due to be escalated to the next step within the hierarchy of enforcement, the unannounced inspector must undertake the required enforcement action (for example, drafting a notice such a HIN or a RAN).
Enforcement undertaken needs to be done in a timely manner. Any formal enforcement completed by FSA employed staff, including written advice, needs to be submitted to the FVC for checking prior to serving. In the case of the SDP, enforcement decisions will be taken by the VEDMs following their established process.

Where during the UAI, the inspector has identified a non-compliant product and evidence indicates that the cause of the non-compliance has originated at a slaughterhouse or other plant under FSA supervision, the unannounced inspector must complete the Internal Communication of Non-Compliance Report (ENF 11/22) and gather evidence /deal with the affected products as per the instructions on the guidance section of the form.

Non-compliant products in which the cause of the non-compliance has originated in establishments approved under the Local Authorities and issues with imported products imported need to be reported to the FVC. Photos relevant to the contraventions identified and copies of notices and/or letters should be uploaded to the premises folder on SharePoint. 

4.7.3.5 Timesheets

Authorised Officers (AOs) that carry out UAIs at FSA meat establishments are required to complete a timesheet to record certain activities related to those official controls. 
Charging for UAIs needs to be done in accordance with the “Time Recording Coding – Additional Guidance for Authorised Officers conducting Unannounced Inspections”. This document should be read in conjunction with the “e-Timesheet User Guide-Coding Guidance”. Both documents are available in the UAI application. 

4.7.4 Complaints

There is no statutory right of appeal against the outcome of an UAI or decision(s). However, if an FBO is aggrieved and seeks to challenge that outcome/decision(s), they may do so by promptly applying to the court for permission to issue a Judicial Review claim. 

Where an FBO is dissatisfied with how the UAI was undertaken and wish to complain, they need to follow the FSA’s complaint process. Details of the FSA Complaints Policy can be noted here.

4.8 Enforcement

4.8.1 Slaughterhouses, game handling and co-located cutting plants

At Full Audit Auditor identifies NC (new & from the enforcement programme):
1.    Urgent Improvement Necessary. Next full audit in 2 calendar months
Resident OV enforces/updates Enforcement Programme and feeds back to auditor on NCs (New and from Enforcement Programme)
Partial audit within 1 calendar month unless Full audit scheduled in that calendar month:

• If all Majors/Criticals are not closed another partial audit takes place within 1 calendar month.
• If all Majors/Criticals are closed, the auditor closes the non-compliances and no partial audits will take place until the next Full Audit.

2.    Improvement Necessary. Next full audit in 3 calendar months
Resident OV enforces/updates Enforcement Programme and feeds back to auditor on NCs (New and from Enforcement Programme)
Partial audit within 1 calendar month unless Full audit scheduled in that calendar month

• If all Majors are not closed another partial audit takes place within 1 calendar month.
• If all Majors are closed, the auditor closes the non-compliances and no partial audits will take place until the next Full Audit.

3.    Generally Satisfactory. Next full audit in 12 calendar months
Resident OV enforces/updates Enforcement Programme and feeds back to auditor on NCs (New and from Enforcement Programme)
Partial audit within 3 calendar months unless Full audit scheduled in that calendar month

• If all Majors are not closed another partial audit takes place within 3 calendar months.
• If all Majors are closed, the auditor closes the non-compliances and no partial audits will take place until the next Full Audit.

4.    Good. Next audit in 18/12 calendar months
Resident OV enforces/updates Enforcement Programme and feeds back to auditor on NCs (New and from Enforcement Programme)

No partial audit takes place until the next Full Audit.

These courses of actions are summarised in the chart below.
 

Note: This chart does not include the extended audit frequency for establishments with Good / Good outcomes in their last two audits. 

4.8.2 Stand-alone cutting plants

At Full Audit Auditor identifies NC (new & from the enforcement programme):
1.    Urgent Improvement Necessary. Next full audit in 2 calendar months
New minor Non-compliances. Auditor serves enforcement / updates ENF passes ownership to UAI process.
New Critical/Major non-compliances identified at Full Audit. Auditor serves enforcement / updates Enforcement Programme and follows the hierarchy of enforcement until closed.
Partial audit within 1 calendar month unless Full audit scheduled in that calendar month:

• If all Majors/Criticals are not closed another partial audit takes place within 1 calendar month.
• If all Majors/Criticals are closed, the auditor closes the non-compliances and no partial audits will take place until the next Full Audit.

2.    Improvement Necessary. Next full audit in 3 calendar months
New minor Non-compliances. Auditor serves enforcement / updates ENF passes ownership to UAI process.
New Major non-compliances identified at Full Audit. Auditor serves enforcement / updates Enforcement Programme and follows the hierarchy of enforcement until closed.
Partial audit within 1 calendar month unless Full audit scheduled in that calendar month

• If all Majors are not closed another partial audit takes place within 1 calendar month.
• If all Majors are closed, the auditor closes the non-compliances and no partial audits will take place until the next Full Audit.

3.    Generally Satisfactory. Next full audit in 12 calendar months
New minor Non-compliances. Auditor serves enforcement / updates ENF passes ownership to UAI process.
Partial audit within 3 calendar months unless Full audit scheduled in that calendar month

• If all Majors are not closed another partial audit takes place within 3 calendar months.
• If all Majors are closed, the auditor closes the non-compliances and no partial audits will take place until the next Full Audit.

4.    Good. Next audit in 12 calendar months
New minor Non-compliances. Auditor serves enforcement / updates ENF passes ownership to UAI process.
No partial audit takes place until the next Full Audit.

In all 4 Full Audit Categories the UAI Process monitors all Minor, Major and Critical Non-compliances and feeds back to the Auditor.

These courses of actions are summarised in the chart below.
 

Note: This chart does not include the extended audit frequency for establishments with Good / Good outcomes in their last two audits.

4.9 Remote Auditing

4.9.1 Background and purpose

Auditors utilise an approved software to conduct Remote Audits, which is in compliance with the FSA security policies available at Privacy notice for audits of slaughterhouses and GHEs and a specific document for the security of the software used for Remote Audits is available at TEXO_Data_Protection_(GDPR)_Procedure.pdf.

4.9.2 Definitions

In accordance to how the audit is carried out, there are 3 main types of audits:

• On-site audit: An FSA audit involving on-site visit and auditing of documents/records at the premises.

• Remote audit: An FSA audit carried out by the auditor without visiting the site but supported by the FSA team (input from all Authorised Officers -AOs visiting the plant) and/or the evidence provided electronically by the Food Business Operator (FBO).
• Semi-remote audit: An FSA audit with a reduced on-site component in which part of the audit is carried out on-site (for example targeted physical checks) and part completed remotely (for example documentation/records, meetings).

4.9.3 When to use Remote Audits?

The Auditor will have to assess the suitability of this technology depending on the outcome of the previous Full Audit, the FBO’s availability and the possibility to use it due to coverage in the establishment. 
The decision tree below can help deciding when a Partial Audit is eligible for remote auditing using remote technology.

Full Audit:
Always requires On-site visit.

Partial Audit:

There are some circumstances where partial audits can take place remotely. 

a.    Previous outcome IN or UIN requires on-site visit
b.    Previous outcome Generally Satisfactory. Eligible for Remote Partial Audit until all Major Non-compliances are closed.
1.    The nature of the Non-compliance allow for remote assessment:

• The FBO is capable / willing to use the technology.
  -   The technology can be used in this establishment. Partial audit to be done remotely.
  -   The technology cannot be used in this establishment. On-site visit.
• The FBO is not capable /willing to use the technology. On-site visit required.

2.    The nature of the Non-compliance doesn’t allow for remote assessment. On-site visit required.
c.    Previous outcome Good. No partial audit required.

In cases where the use of the FSA application (Fuse) is not possible, alternative technology/tools can be used for a remote partial audit with only documentary non-compliance, as a virtual tour of the premises is not required. Virtual tours can only be done using the FSA application.

These courses of actions are summarised in the chart below.

Updated [

]

5. Risk Assessment

In this section

5.1 Audit report

5.2 Audit compliance assessment

5.3 Audit outcome and frequency

5.4 Review and right of appeal

5.1 Audit report

5.1.1 Audit report form

The Audit report form (AUD 9/3) is available via the K2 system.

5.1.2 Summary of findings

The report contains an area to summarise the audit findings. The summary of findings should include positive findings (good practice), negative findings (NCs) and a brief description of any variations from the previous audit enabling the FBO and other interested parties to review the audit without needing to read the full detail contained within the report.

5.1.3 Non-Compliance Report (NCR)

At the end of the audit report there is a section containing the NCR. 

The NCR summarises and provides a short description of the NCs identified.

Once the FBO receives the report with the NCR, the FBO is responsible for rectifying the NC identified during the audit.

5.1.4 Correction of NC

During the next audit, the auditor must verify whether the FBO has taken corrective actions and indicate those which have been completed.

5.2 Audit compliance assessment

5.2.1 FBO compliance history

The history of compliance relates to the deficiencies identified against legislative requirements or the FBOs own procedures and requiring OV intervention during the audit interval or the ongoing NCs from the previous full audit.

Note: FBO initiating corrective actions where the FBO has identified a breakdown in controls is a sign of a healthy food safety management system.

During the audit, the auditor will record evidence of the FBO compliance history, which will result in a risk score under each category based on the following criteria and type of NC:

 

Title	Description
Compliant	Compliance with a food safety programme, food regulatory requirements and animal health and welfare regulations (in the case of slaughterhouses) is achieved if the food business is operating in accordance with its food safety management systems, food safety standards and has met the requirements of the regulations.
Minor	A NC that is not likely to compromise public health (including food safety), animal health and welfare or lead to the handling of unsafe or unsuitable food. An isolated low-risk situation and does not compromise achieving control measures of the food safety program; that is, overall the food safety program is still effective in controlling the food safety hazards. When viewed collectively a number of related minor NCs may represent a major NC. Examples (not exhaustive): a single monitoring lapse of a process that is shown to be otherwise under control minor structural defects minor failure to follow good hygienic procedures specified in prerequisite programs ineffective pest control in a limited area slight variation from documented procedures inadequate cleaning in a limited area a few signatures missing on a record over a short time period intermittent or poor completion of records.
Major	A major NC is a one that is likely to compromise public health (including food safety), animal health and welfare or may lead to the production and handling of unsafe or unsuitable food if no remedial action is taken. When viewed collectively a number of related major NCs may represent critical NC. Examples (not exhaustive): complete departure from procedures contained in the food safety, animal health and welfare program  incomplete action for washing and sanitising procedures inadequate staff training leading to unhygienic practices recurrent monitoring lapses of a process numerous structural defects, with potential impact in food safety or animal welfare failure to follow good hygienic procedures specified in prerequisite programs
Critical	A critical NC is one where the contravention poses an imminent and serious risk to public health (including food safety), animal health and welfare. Examples (not exhaustive): systemic failure of critical aspects of the FBO practices and procedures for implementing food safety, animal health and welfare regulatory requirements a serious pest infestation  intentional falsification of records the same chopping board and knife being used for ready to eat food after being used for raw chicken without being cleaned and sanitised evidence of pest control chemicals such as rat bait in food raw meat juices dripping onto uncovered ready to eat food repetitive (more than once) major NC for the same practice or circumstance

5.2.2 Audit categories

Using objective evidence, the type of NCs identified during an audit reflects the extent and effectiveness of compliance. The following grading system is outlined in the table below:

 

Compliance rating	Description	Tolerance for audit outcome
Good	No issues of significance for public health, animal health or animal welfare during the entire audit period.	No majors or critical on day of audit or during audit period
Generally Satisfactory	No immediate issues of significance for public health, animal health or animal welfare identified on the day of the audit. Any NCs identified during the audit period corrected promptly.	No more than 2 majors during audit or during audit period rectified promptly No critical during audit period
Improvement Necessary	Major NCs identified at audit and/or NCs during the audit period not always responded to and corrected promptly.	3-6 majors during audit or during audit period No critical during audit period
Urgent Improvement Necessary	Multiple major NCs or critical NC identified during audit visit or interim audit period. Official intervention required to ensure public health safeguards.	1 critical or >6 majors during audit or during audit period

5.3 Audit outcome and frequency of inspections

5.3.1 Determination of frequency

The frequency of audit reporting is determined on a risk basis; assessed, in part, on the outcome of previous audits as outlined in this chapter.

The scheme differentiates between slaughterhouses with or without co-located cutting plants, approved GHE and standalone cutting plants. Audit frequency for slaughterhouses / co-located cutting plants / approved GHE ranges from 2 to 18 months and for standalone cutting plants ranges from 2 to 12 months (due to an absence of routine official presence in standalone cutting plants 12 months remains the maximum frequency).

In addition to a scheduled full audit, a follow up partial audit is to be carried out in some establishments which is dependent on the full audit outcome.

5.3.2 Audit frequency

Please also see sub topic 5.3.3 Extended audit frequency.

The tables below list the minimum audit frequencies applicable to specific types of food establishment. They also include the number of necessary partial audits and UAIs that have to take place.

Updated [Audit frequencies for slaughterhouse / co-located cutting plants and approved game handling establishments

Audit outcome	Follow up partial audit	Full audit frequency
Good	0	18 months*
Generally satisfactory	Within 3 months*	12 months
Improvement necessary	Within 1 month	3 months
Urgent Improvement necessary	Within 1 month	2 months

* Where there is sufficient evidence provided to the auditor by the FBO, and verified by the OV where possible, that the NC has been rectified, this can be closed off without the need for an establishment visit (it is at the discretion of auditor to decide if a visit is required). This is only possible if the audit outcome is ‘generally satisfactory’.]

Audit frequencies for standalone cutting plants and cold stores (for example, Smithfield Market)

Audit outcome	Follow up partial audit	Minimum number of UAIs during interim audit period*	Full audit frequency
Good	0	1	12 months
Generally Satisfactory	Within 3 months	1	12 months
Improvement necessary	Within 1 month	1	3 months
Urgent Improvement necessary	Within 1 month	1	2 months

*RTE establishments will receive one additional unannounced inspection by a trained OV.

Additional visits based on the audit outcome

Audit Outcome	Revisits
Good	N/A
Generally Satisfactory or Improvement Necessary	Follow up partial audits (where required) to be carried out by the auditor Unannounced inspections to be carried out by a MHI or an OV (for example, in RTE establishments or co-located cutting plants) Major NCs in all instances shall be closed off by the auditor either following a site visit or upon acceptance of corroborated evidence of compliance Minor NCs can be signed off by the auditor upon information received by the field team
Urgent Improvement Necessary	Follow up partial audits (where required) to be carried out by the auditor Unannounced inspections to be carried out by a MHI or an OV (for example, in RTE establishments or co-located cutting plants) Critical NCs can only be closed off by the auditor following an on-site partial audit where compliance could be verified Major NCs in all instances shall be closed off by the auditor either following a site visit or upon acceptance of corroborated evidence of compliance Minor NCs can be signed off by the auditor upon information received by the field team

5.3.3 Extended audit frequency

Extending audit frequency aims to provide recognition for FBOs who have sustained a high level of compliance over two consecutive audit outcomes with an aim to ultimately reducing footfall resulting from official control activities without increasing the risk to consumer protection or confidence.

The tables below list the minimum audit frequencies applicable to specific types of food establishment. They also include the number of necessary partial audits and UAIs that have to take place.

The FSA reserves the right to re-audit meat premises at any time and will act on intelligence and evidence in line with existing intervention protocols. Taking compliance history into consideration encourages businesses to maintain high standards at all times.

Extended audit frequencies for slaughterhouses / co-located cutting plants and approved game handling establishments

Audit outcome	Standard frequency	Follow up partial audit	Extended frequency
Good / Good	18 months	0	36 months

Extended audit frequencies for standalone cutting plants and cold stores

Audit outcome	Follow up partial audit	Minimum number of UAIs during interim audit period	Current full audit frequency	Extended frequency	Minimum number of UAIs during interim audit period
Good/ Good	0	1	12 months	24 months	2

RTE establishments will receive one additional (3) UAIs during the interim audit period by a trained OV.

Any plant that qualified for extended audit frequencies and subsequent audit outcomes drop to Generally Satisfactory, Improvement Necessary or Urgent Improvement Necessary is automatically disqualified from the extended audit frequency system. They can requalify for extended audit frequencies by achieving two consecutive Good / Good outcomes, but, in the meantime, will revert back to standard audit frequencies.

However, if during the full audit of an establishment that is under the extended audit frequency, the auditor raises a Critical/Major NC for deficiencies that have occurred during the extended period but for which the FBO implemented remedial/preventive actions promptly and effectively with no recurrence observed (or reported by the OV/UAI) afterwards, the NC can be “closed do not count to outcome”. This decision is at the auditor's professional judgment for isolated issues fully resolved at the time of the audit, in consultation with the AVL.

In these cases, the audit's outcome will be ‘Good’, but there will be an impact on the Extended Audit Frequency (EAF) status, as this will be removed until the next audit. The auditor will have to communicate to the K2 team the need to change the EAF status manually; otherwise, the K2 system will automatically include the establishment in the EAF. The status can be re-gained if a Good outcome, with no other Critical/Major NCs within the second audit cycle, is achieved.

5.4 Review and right of appeal

5.4.1 Regulators code

The appeals route for FBO audits follows the regulators code.

5.4.2 FBO right to seek review

If an FBO is dissatisfied with the outcome of discussions with the auditor after the closing meeting, or the audit report once received from the Updated [FSA Veterinary Audit Team (VAT)], the FBO has the right of appeal in line with the following procedures:

 

Stage 1 Appeal	Action
Try to resolve informally	All efforts should be made to resolve any misunderstanding or dissatisfaction informally on a local basis between the auditor, AVL and FBO.
Direct FBO to Updated [the approvals team] to request an audit appeal form	If a FBO, or their representative, still wishes to appeal an audit report they should be directed to the Updated [approvals team] to request the audit appeal form ‘Request for a review of the audit of the FBOs food safety management system’.
Updated [Approvals] receives request for audit appeal form	On receipt of the FBO’s request for an appeal request form, the Updated [approvals team] will send the form to the FBO, ensuring that the auditor is notified of the request, to ensure that all possible efforts have been made to resolve the matter informally.
FBO submits formal appeal, with supporting evidence	The FBO, or their representative, should complete their part of the form, stating which sections of the audit report the FBO is appealing against and giving objective evidence to support the claim that the auditor’s assessment is incorrect.  Any supporting evidence should be copied and sent with the form to the Audit Coordinator within 14 calendar days of receiving the initial audit report.  Appeals which are not supported with objective evidence may be rejected.
Investigating Officer (IO) appointed	Updated [On receipt of the completed appeal form, the approvals team will provide the Head of Veterinary Audit with a copy of the appeal, including any supporting evidence. The Head of the Veterinary Audit will be responsible for appointing an AVL from a different area as the Investigating Officer (IO), and confirming the details. Note: The VAT will also advise FSA Finance and relevant local teams that the audit is under appeal].
IO reviews the supporting evidence supplied by the FBO	The IO will consider if the appeal has sufficient evidence to continue, if not the FBO will be notified that the appeal will not progress any further.  IOs will focus on scores challenged and the submission of evidence to carry out the investigation. The IO is not obliged to examine other aspects of the audit to which the appeal is related; however, as findings are sometimes interrelated the IO will take these into account where it is appropriate to do so. The IO will not overlook other relevant information which may be used to inform any decision made.
IO conducts an investigation	The IO conducts an investigation and completes a report before the last date for completion (stated in part 1 of the appeal request form). The IO will determine which considerations should be made when making the assessment. Examples as follows: refer to audit notes request documents from FSA / FBO discuss with auditor and FBO visit an establishment or not; telephone interviews may be sufficient to clarify doubts Note: IOs should always consider visits to premises where serious concerns are arising, such as critical or multiple major NCs.
Investigation outcome	Updated [On conclusion, the IO distributes their completed report to the approvals team, who will take the necessary actions, depending upon the outcome of the IO’s investigation. The approvals team will email the IO’s report to the FBO, (including any amended audit report if applicable) and copy the correspondence to the AVL and the Head of the Veterinary Audit Team]. The IO is responsible for discussing the investigation findings with the AVL, auditor and the FBO (or their representative) regardless of whether the investigation report resulted in an amendment or the score was upheld.

5.4.3 Stage 2 appeals

FBOs can request a Stage 2 appeal when they are not satisfied with the outcome of the stage 1 appeal. 

A £250 fee is payable by the FBO for a stage 2 appeal process as a contribution to the FSA’s costs. Stage 2 appeals will not commence until the fee has been paid. If the review/appeal rules in the FBO’s favour and the audit frequency has been changed the £250 will be refunded. If the appeal changes the outcome of some sections, but this does not lead to a change in the overall audit outcome, the fee will not be refunded.

 

Stage 2 Appeal	Action
FBO exercises their right to appeal at stage 2	FBO notifies the Updated [Approvals Team] in writing (for example, via email or post) within 7 calendar days of receiving the stage 1 outcome notification of his intention to appeal the stage 1 outcome. The required £250 payment should also be enclosed.
Updated [Approvals]  receives FBO written confirmation and payment	On clearance of payment Updated [the Head of the Veterinary Audit Team] will contact an independent IO appointed by the FSA to carry out the investigation. Stage 1 appeals pack is sent to Independent IO for review. Updated [This is made of: the audit report the FBO appeal the IO report link to the audit chapter of the MOC any additional document reviewed during the stage 1 appeal]
Independent IO	The appeal will be determined within 14 calendar days by the independent person nominated by the FSA.  The nominated person: Updated [will give the business and the FSA an opportunity to make representations on the matter to be determined in written, followed by an interview with the FBO] Updated [will interview the auditor and the IO involved in the stage 1 of the appeal] Updated [once all the information is reviewed, the IO will write up a report with the conclusion of the appeal, including any evidence required to support his decision] will notify the FBO and the Operations Head Veterinarian of the final decision  If the independent IO decides in favour of the FBO and provided the audit outcome has been changed the £250 fee for initiating the appeals process would be refunded to the business.

5.4.4 Updated [Continuation of the audit process

Whilst the appeal process is taking place, the audit schedule continues as normal. If the outcome of the appeal supports the FBO claims and this impacts on the audit outcome, the audit frequency will be adjusted to the new outcome in line with the MOC instructions.

During the appeal process the audit outcome will not be published on the FSA website].

6. Annexes

Note: These pages can only be accessed by FSA staff on FSA devices.

Annex 1: Audit aide memoire

Annex 2: Audit writing guidance

Annex 3: Audit preparation Checklist

Annex 4: Audit Checklist 

Annex 5: Audit training notes

Annex 6: FBO audit cancellation letter template