Workshop on Standard operating procedures in the phytosanitary field, September Belgrad Serbia Monica Maria COJANU, Romania

Quality management system Scope: Development and control of documents applicable to the Quality Management System covers the following : coding, drawing, review, approval, distribution, use, access, storage, revision, withdrawal, storage and disposal of records Management Control System Purpose system is applied to all documents and activities including external documents on paper or electronically

Reference documents Quality management system principles and vocabulary SR EN ISO 9000: 2006 Order on standards of management and internal control public entities and to develop management control systems in Romania Order on the establishment and powers of monitoring, coordination and methodological guidance of management control system Regulation of organization and functioning of the Commission EU and national legislation in force

What is a Standard Operating Procedure? Principles and vocabulary of SR EN 9000:2006 Specified way to carry out an activity or a process All steps to be followed, methods of working and rules applied set in order to carry out an activity, duty or task Procedures can be documented or not EN ISO 9000: 2006 Quality management systems Fundamentals and vocabulary

Why do we need Documented Procedures/SOPs?,,,Documented procedure” or,,written procedure” is frequently used a set of written instructions that substantiates an action or repetitive activity in a public institution procedure has not be an excessive bureaucratization is a tool that facilitates the work as quickly and effectively correct possible

Type of procedures The general procedure describes an activity or process that takes place in all departments of the institution called,,system procedure” The specific procedure describes an activity or process that takes place in one or more departments of the institution called,,operational procedure’’ or,,procedure for process’’

The general procedures The General Procedure of drawing and control documents The other General Procedures Circulation documentary, Recording Organizing committee meetings, Risk management, Sensitive functions, Reporting irregularities, Delegation, Unauthorized access in the institution

The specific procedures The specific procedures on Sampling and analysis in the official controls to achieve objectives of EU or national legislation Pesticide residues analysed in foodstuff of nonanimal origin Contaminants COMMISSION DIRECTIVE 2002/63/EC of 11 July 2002 COMMISSION DIRECTIVE 2002/63/EC of 11 July 2002 Establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC REGULATION (EC) NO 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL REGULATION (EC) NO 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 February 2005 of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

Regulation (CE) 882/ Article 11 Methods of sampling and analysis 1.Sampling and analysis methods used in the context of official controls shall comply with relevant Community rules or, (a) if no such rules exist, with internationally recognised rules or protocols, for example those that the European Committee for Standardisation (CEN) has accepted or those agreed in national legislation; or, (b) in the absence of the above, with other methods fit for the intended purpose or developed in accordance with scientific protocols. 2. Where paragraph 1 does not apply, validation of methods of analysis may take place within a single laboratory according to an internationally accepted protocol.

Why sampling for analysis is so important? Regulation (CE) 882/2004 Article 4, Designation of competent authorities and operational criteria […] 2. The competent authorities shall ensure: (a) the effectiveness and appropriateness of official controls […] A sampling for analysis ineffective and/or inappropriate will render ineffective and/or inappropriate the analytical measurements!

Article 8 - Increased level of official controls at designated points of entry The competent authority at the designated point of entry shall carry out without undue delay: (a) documentary checks on all consignments […]; (b) identity and physical checks, including laboratory analysis, at the frequencies set out in Annex I, and in such a way that it is not possible for feed and food business operators or their representatives to predict whether any particular consignment will be subjected to such checks […] PROCESS ACTIVITIES

Management process Increased level of official controls at designated points of entry (Process) documentary checks identity checks physical checks (Activities) What is/are the input(s)? Are the activities planned (when/if possible)? Who is responsible? How should the activities be carried out? Are the processes carried out under controlled conditions? What resources are necessary? What is/are the output(s) Documented procedures

EN Standards: processes and procedures Procedure Specified way to carry out an activity or a process Note 1 Procedures can be documented or not. Note 2 When a procedure is documented, the term "written procedure" or "documented procedure" is frequently used. Process Set of interrelated or interacting activities which transforms inputs into outputs. Note 1 Inputs to a process are generally outputs of other processes. Note 2 Processes in an organization are generally planned and carried out under controlled conditions to add value Product Result of a process EN ISO 9000: 2006 Quality management systems Fundamentals and vocabulary

SOP-s applicable by NSVFSA The following categories of SOP-s are applied by the NSVFSA General procedures Specific procedures Manuals Instructions for working Forms Registers Questionnaires

Necessary SOP-s All documents are available under supervision of staff by posting on the website or intranet The commission to ensure that they are updated regularly legible and accurate The needs of SOP-s are set by the President and Directors taken into consideration by the organizational structures in accordance with the standards applicable requirements management / internal control of public institution

Drawing of SOP-s by people who have good knowledge of drafting techniques' activities described and procedures developing The general procedures are performed by members of the committee or working groups The specific procedures, instructions and guidelines specific to different directions is performed by technical staff

Commission The Commission is monitoring and coordinating methodology guidance of management control system of NSVFSA Components of the commission a) President- Secretary General of NSVFSA b) Vice-President- General Director from General Directorate c) Members- Directors, head of units or representative from each directorate, unit or service

Approval documents The approval and data entry into force is specified on guard page The General procedures and applicable documents for whole authority by the President The Specific procedures, instructions, guidelines by the Director General / Director / Head of Service / Head Office

Verification of SOP-s The general procedures and documents applicable to the entire authority is made by committee The specific procedures, instructions guidelines specific to different directions is performed by persons designated in these structures

Delivering of SOPs Can be delivered electronic or printing Have to be published on web page of authority The commission has registered and take evidence if the other revision has been replaced

Using of SOP-s The personal have to ensure that they are used the updated and enforcement version and to consult the enforcement list of SOP-s Each document has to specify Revision Edition Data for enforcement Storage and access to personal

Document format Guard page Indicator editions and revisions List of distribution- multiple application for archiving, record, information … Contents and Chapter Data of identification

Drafting SOP-s on official control SOP concerning methods of sampling for analysis looking for their suitability to achieve objectives fixed in the EU legislation

Regulation (CE) 882/2004 – Art. 11 Methods of sampling and analysis Sampling and analysis methods used in the context of official controls shall comply with relevant Community rules or, (a) if no such rules exist, with internationally recognised rules or protocols, for example those that the European Committee for Standardisation (CEN) has accepted or those agreed in national legislation;or, (b) in the absence of the above, with other methods fit for the intended purpose or developed in accordance with scientific protocols.

Regulation 882/2004 Evaluation of documented procedures Art. 2 (6). ‘Audit’ means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives

Regulation (CE) 882/2004 and documented procedures 1. Competent authorities shall carry out official controls in accordance with documented procedures. These procedures shall contain information and instructions for staff performing official controls including, inter alia, the areas referred to in Annex II, Chapter II. 2. […] 3. […] The documentation referred to in paragraph 1 is updated as appropriate.

Regulation 882/2004 Annex II, Competent Authorities Chapter II: Subject Areas For Control Procedures 1. […] 2. […] 3. A statement on the objectives to be achieved 4. Tasks, responsibilities and duties of staff 5. Sampling procedures, control methods and techniques, interpretation of results and consequent decisions 6. Monitoring and surveillance programmes 7. […] 8. Action to be taken following official controls 9. Cooperation with other services or departments that may have relevant responsibilities 10. Verification of the appropriateness of methods of sampling, methods of analysis and detection tests 11. Any other activity or information required for the effective functioning of the official controls.

Conclusions Competent Authorities shall carry out any activity required for the effective functioning of the official controls in accordance with documented procedures. Documented procedures, updated as appropriate, shall contain information and instructions for staff performing official controls Documented procedures enable quality and consistency of official controls

Thank you for attention!