Health and Consumers

Rui Ludovino European Commission – DG Health and Consumers (SANCO)

Deputy Head of Unit Unit G7 - Bilateral International Relations

Audit Cycle

Workshop on "Practical Arrangements for Implementing System Audits and Pre-listing Approach on Imports of Animals and Animal Products between

the European Union (EU) and Thailand"

19 – 20 September 2013

Health and Consumers

Objectives

• Equivalence of the Exporting Country with the Importing Country requirements (production and official controls)

• Follow-up of previous audit

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Audit Cycle

• Audit preparation

• Audit performance

• Audit Reporting

• Follow-up on recommendations

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Audit Preparation

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Audit Preparation • Selection of audit team

• Audit announcement (dates) (60-90 days)

• (FVO mission programme)

• Evaluation plan, and pre-audit questionnaire if needed

• Agreements between TC and EU

• Desk studies (rapid alerts, production/export statistics, country profile, multi-annual control plans, earlier FVO reports, questionnaire)

• List of establishments

• Preparation and agreement on itinerary

• Practical arrangements

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Evaluation/Audit plan

• Objectives and scope of the audit

• Legal basis

• Review of legislation (auditee)

• Performance of the audit (evaluation)

• Competent Authorities;

• Official controls over Food Business Operators;

• Meetings and sites to be visited.

• Documents to be available for the audit team

• Language to be used

• Confidentiality requirements

• Processing and distribution of the report

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Pre-audit questionnaire

• General information

• Legislation

• Competent authority

• Official controls

• Approval and registration

• Sampling procedures

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Itinerary • tool to achieve the goal • the use of the information

collected or received from the CA • Problems at this stage

(establishments suddenly closed, too long travelling, the whole food chain not covered, laboratories not included).

• places to be visited (going to the right places)

• proposed itinerary (CCA or FVO) • comments and remarks • agreement on the final version,

later confirmation at the opening meeting

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Audit performance

• Opening meeting • On-the-spot visits

(offices of the CAs, farms, vessels, landing sites, establishments, laboratories, etc.)

• Closing meeting (presentation of preliminary findings and conclusions)

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Evidence collection

• Interviews and questions • Observations of activities and work environment • Review of documentation • Request checks and measurements to be undertaken

(e.g. temperatures taking, demonstration of sampling/testing, demonstration of equipment functioning).. "show me"

• Ensure sufficient sample of activities, procedures and records are included

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Audit techniques – interviews

• Establish of trust and respect • Be prepared and open • Establish a comfort zone • Clear and open questions

(what when, who, how why) • Closed questions needed

sometimes (e.g. yes/no) • Rephrase/Paraphrase • Exploring the topic - simple

questions) • Split questions -

uncomfortable question divided into separate questions

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Interviews techniques

• Protected questions • Why did you miss the deadline? • How were the deadlines

determined?

• Balanced questions • Preface with praise – e.g. this is a

detailed SOP – how does it work in practice

• Loyal questions • Why don’t you record evidence of? • It must be difficult to keep all this

evidence. Can you tell me more about it?

• Is it manageable to maintain so many records?

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Data and evidence gathering

• Observe • Question • Check records

• Needed: facts • Ensure observations

can be verified/witnessed

• Take notes – actual and accurate, non-compliances and good points

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What is a non-compliance?

• Failure to comply with a standard (e.g. Article 5 of Regulation (EC) No 852/2004 (HACCP)

• Failure to comply with a documented procedure (e.g. monitoring, verification)

• Failure to comply with the Regulations

• Failure to comply with a commercial standard (not a non-compliance)

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What is a non-compliance?

• Recording of non-compliances: • Clear, • Unambiguous, • Factually correct • Objectively written

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Opening meeting (participants)

• Central CA • CA accompanying the team • Interpreters • Auditors

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Opening meeting

• Introductions • Confirmation of audit plan (scope,

objectives, itinerary, etc. ) • Working methods and procedures • Establish official communication line • Confirm any biosecurity

requirements • Confirm resources, facilities and

transportation • Additional documentation required • Reporting procedure

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Visits of CA offices Examination of documentation and interviews

• National legislation • Instructions and guidelines • National control and sampling plans

and results • Audit and inspection reports and

follow-up actions • Documentation on training • Minutes of meetings • Enforcements taken • Databases • Co-ordination and co-operation

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Establishment visits

• Introductions • Interviews

• CA • FBO • Staff in the establishment

• Documentary checks • Official controls – reports, checklists, follow-up • Own controls – HACCP-based programmes, pre-

requisites, traceability

• Establishment tour (whole plant or certain lines)

• Wrap up/feedback

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Official controls

• Who is inspecting? • Training and qualifications of the

inspector? • Frequency – is it based on risk? • Unannounced or announced in

advance? • Duration of the inspection/audit? • Use of aide-memoirs, checklist? • What is inspected and how?

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Official controls

• Inspection reports • Are shortcomings documented? • Are deadlines given to correct

shortcomings? • Is there a follow-up in place? • Is effective enforcement taken

if shortcomings not corrected?

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Official sampling programmes

• Defined at what level (CCA/RCA/LCA)

• Sampling of raw materials • Sampling of final products • Sampling of potable water • Sampling for residues

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Visits to official laboratories

• Accreditation scope and certificate • List of accredited methods • Alternative methods and their

validation certificate • Proficiency tests results • Examples of methods • Examples of test results • Timeliness of test results • Informing of CAs in case of poor

results • Staff training • Calibration of instruments

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Closing meeting

• Thanks • Restatement of audit scope and

objective and criteria used • Evaluation based upon a sampling of

CA performance • Presentation of preliminary findings

and conclusions and their significance in a balanced and objective way

• Confirmation of any outstanding information

• Restatement of reporting procedure • Immediate risks – can lead to request

of immediate guarantees and to safeguard measures

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Back-to-office note

• Short one/two page(s) • Prepared in the first day of return • Preliminary assessment of

overall outcome • Indication of main conclusions • Circulation: within DG SANCO

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Audit reporting procedure

• Draft report within 20 working days (unless urgent)

• Comments from the audited CA within 30 working days (unless urgent)

• Final reports issued after reception of CA comments (which are taken into account)

• Distributed to the EU MS + EU Parliament + Commission services

• Published (SANCO internet website) + comments + action plan

• Confidentiality

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Audit report

• Report template • Contents:

• Executive summary • Introduction • Objectives • Legal basis (Art. 45 for EU MS /

Art. 46 for TC; Reg. 882/2004) • Background • Findings and conclusions • Overall Conclusions • Closing meeting • Recommendations • Legal references

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Audit follow-up

• Exchange of correspondence • Submission of guarantees • Action plan • Classification of actions

• Satisfactory – closed • Unsatisfactory – clarification request • No response – clarification request

• Reminder letter • Follow-up audit (risk based)

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FVO Audit programme criteria Priority and frequency is risk based

• Regulatory (new legislation / requirements)

• Trade volume (high) • Degree of risk associated with the

product • Contagious diseases / zoonoses • Specific high risks (biotoxins / histamine) • Confidence in the exporting country • (history of compliance, RASFFs,

rejections)

• Strategic (minimum frequencies – 3 to 5 years)

• Request for new market access

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Additional questions