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
Health and Consumers
Audit Cycle
• Audit preparation
• Audit performance
• Audit Reporting
• Follow-up on recommendations
Health and Consumers
Audit Preparation
Health and Consumers
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
Health and Consumers
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
Health and Consumers
Pre-audit questionnaire
• General information
• Legislation
• Competent authority
• Official controls
• Approval and registration
• Sampling procedures
Health and Consumers
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
Health and Consumers
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)
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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?
Health and Consumers
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
Health and Consumers
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)
Health and Consumers
What is a non-compliance?
• Recording of non-compliances: • Clear, • Unambiguous, • Factually correct • Objectively written
Health and Consumers
Opening meeting (participants)
• Central CA • CA accompanying the team • Interpreters • Auditors
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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?
Health and Consumers
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?
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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
Health and Consumers
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)
Health and Consumers
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
Health and Consumers
Additional questions