Animal Products (Dairy) Conditions for Recognition. June Final

Transcription

1 Conditions for Recognition June 2005

2 Table of Contents 1 Scope Outcome Issuing and Availability of Conditions Conditions for Recognition Duties For Recognised Agencies Part 1 Laboratories Conditions for Dairy Laboratories...7 CONDITION CONDITION CONDITION CONDITION Part 2 Recognised Agencies and Persons Conditions for Recognised Agencies and Persons...9 CONDITION CONDITION CONDITION CONDITION CONDITION CONDITION CONDITION Verification Laboratories Test Methods Recognised Agencies and Persons...12 Conditions for Recognition 1 June 2005

3 1 Scope This document outlines the conditions for recognition of agencies and persons under the Animal Products Act 1999 for the dairy industry. Recognised agencies include laboratories and also persons who are recognised by NZFSA to perform evaluation and verification of registered Risk Management Programmes for the dairy industry. Conditions for Recognition 2 June 2005

4 2 Outcome This document sets out the conditions that recognised agencies and persons must comply with to be recognised by NZFSA Dairy and Plants. The conditions outlined in this document are the generic requirements to be met by a recognised agency or person for recognition. The document also outlines the process for issuing conditions of recognition and where this information may be found. Conditions for Recognition 3 June 2005

5 3 Issuing and Availability of Conditions This document outlines all conditions that apply to all recognised agencies and persons and is available on the Dairy and Plants website so that prospective agencies and persons are aware of the conditions that have to be met. The document has been split so requirements for laboratories and agencies and persons who evaluate and verify Risk Management Programmes are separate. Once an agency has been accredited or recognised to the appropriate standard (ISO for Category One laboratories, relevant Parts of the Animal Products (Dairy) Recognised Agency Specification and the Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons for Category Two laboratories or ISO for evaluators and verifiers of Risk Management Programmes) and a recommendation has been provided to NZFSA Dairy and Plants for recognition, then they will be recognised providing they comply with the conditions in this document. The Director-General must supply a notice of recognition to any successful applicant who applies for recognition as an agency or person under section 103 of the Animal Products Act Any conditions for recognition of an agency or person under the Act are issued under section 105. Conditions may be generic and apply to all recognised agencies and persons or may be specific to an agency or person. A notice of recognition will contain all relevant conditions contained in this document as well as any specific conditions for the agency or person. Approved alternatives to the approved criteria outlined in the document titled Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons must be specified in the notice of recognition and made available to the accreditation or recognition body. Conditions for Recognition 4 June 2005

6 4 Conditions for Recognition (1) In this document, unless the context otherwise requires accreditation body means an internationally recognised, independent, non-profit organisation which is authorised to accredit organisations to certain ISO standards Act means the Animal Products Act 1999, unless otherwise stated Director-General means the Chief Executive of the Ministry, under the Minister, responsible for the administration of the Act evaluation means the process of independent external assessment of the validity of a risk management programme for the purposes of providing an independent evaluation report as required under section 20(2)(b) of the Act recognition body means an organisation approved by NZFSA to recognise Category 2 dairy laboratories validate in relation to a risk management programme means the process by which the operator ensures that the programme is complete, and meets the requirements of the Act and any relevant animal product regulations and specifications; and when implemented, will consistently achieve the required outcomes of the programme; and re-validate has a corresponding meaning verification in relation to a risk management programme means the ongoing checks carried out by recognised agencies and persons described in section 35 of the Act (2) Any term or expression that is defined in the Animal Products Act 1999, Animal Products (Ancillary and Transitional Provisions) Act 1999, or regulations made under those Acts and used, but not defined, in this notice has the same meaning as in those Acts or regulations Conditions for Recognition 5 June 2005

7 5 Duties For Recognised Agencies Section 106 of the Animal Products Act sets out duties that a recognised agency must perform. An agency must: a) ensure all recognised persons employed, engaged or used by it are not placed in a situation which compromises their impartiality and independence in relation to the performance of their functions and duties; b) ensure that it has adequate resources and that its systems are maintained to ensure it can carry out its functions and activities; c) ensure that where a particular function or activity is required to be carried out by a recognised agency, that those functions and activities are carried out only by an agency recognised under the Act to undertake responsibility for that function or activity; d) ensure that where a particular function or activity is required to be carried out by a recognised person who is required to be under the management of a recognised agency, that those functions and activities are carried out only by a person under the management of a recognised agency and who is recognised under the Act to undertake that function or activity. The Animal Products Act sets out a number of duties for recognised persons in section 107. These have been paraphrased as follows: Undertake only functions and activities that are conferred on them by the Director- General Comply with the relevant requirements of any regulation or specification in force under the Act and any directions given by the Director-General under section 81 of the Act Maintain appropriate degree of impartiality and independence in carrying out functions and activities as a recognised person Maintain appropriate degree of confidentiality relating to the activities and operations contacted in the performance of functions and activities Report to the appropriate Ministry official any matter required to be reported on under the Act. Conditions for Recognition 6 June 2005

8 6 Part 1 Laboratories 6.1 Conditions for Dairy Laboratories This Part contains the conditions for recognition of dairy laboratories, including recognition of: Category 1 laboratories that test dairy material for export certification and samples to determine whether fit for intended purpose or to meet Overseas Market Access Requirements; Category 2 laboratories that test the company s dairy material for sale in the New Zealand domestic market, and samples (including raw milk) for internal quality control purposes; and in-process laboratories that test dairy material, the results of which are used as a basis for rationalised testing of dairy material to determine whether dairy material is fit for intended purpose or to meet Overseas Market Access Requirements. CONDITION 1 All NZFSA-recognised dairy laboratories must comply with mandatory requirements set out in Part 2 of the Animal Products (Dairy) Recognised Agency Specification. CONDITION 2 All test methods used to verify conformance of dairy material to regulatory requirements, and/or with attestations provided by NZFSA in official assurances, must approved by NZFSA in accordance with the requirements in Part 2 of the Animal Products (Dairy) Recognised Agency Specification. CONDITION 3 All NZFSA-recognised dairy laboratories must comply with the approved criteria outlined in the Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons or an alternative approved as being equivalent by NZFSA. Conditions for Recognition 7 June 2005

9 CONDITION 4 All NZFSA-recognised dairy laboratories must implement the assessment frequency for Performance Based Verification specified by NZFSA: Dairy & Plants based on recommendations by the accreditation/recognition body. Conditions for Recognition 8 June 2005

10 7 Part 2 Recognised Agencies and Persons 7.1 Conditions for Recognised Agencies and Persons This Part contains the conditions of recognition for agencies and persons who provide evaluation and verification services to the New Zealand dairy industry. All Recognised Agencies and their associated persons must comply with these conditions to be recognised by NZFSA Dairy and Plants and in order to maintain recognition. CONDITION 1 All NZFSA-recognised dairy agencies and persons must comply with mandatory requirements set out in Part 3 of the Animal Products (Dairy) Recognised Agency Specification. CONDITION 2 All NZFSA-recognised dairy agencies and persons must comply with the approved criteria outlined in the Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons or an alternative approved as being equivalent by NZFSA. CONDITION 3 All NZFSA-recognised dairy agencies and persons must implement the assessment frequency for Performance Based Verification specified by NZFSA: Dairy & Plants based on a recommendation by the accreditation body. CONDITION 4 Where there is a change in the directorship, management, or control of a recognised agency, the agency must notify the NZFSA as soon as practicable in writing, for the purpose of ensuring that the requirements of section 100(2) of the Act have been met. The purpose of this requirement is to ensure that fit and proper person test will continue to be met. Conditions for Recognition 9 June 2005

11 CONDITION 5 The recognised agency must apply Performance Based Verification to all Risk Management Programmes registered under the Animal Products Act 1999 at the frequency specified by NZFSA. CONDITION 6 Where a person is recognised by NZFSA to evaluate or verify Risk Management Programmes is prevented from exercising his or her rights under a Risk Management Programme, that person must advise their managing recognised agency and the Director Dairy and Plant Products as soon as practicable; and recommend any actions to be taken; and confirm the advice to the Director Dairy and Plant Products, in writing. CONDITION 7 To maintain recognition, the recognised agency must a) ensure that it is fully assessed by an accreditation body at least every two years from the anniversary date of the recognition to determine that it still meets the requirements of ISO and any supplementary criteria; and b) in every alternate year ensure that an accreditation body conducts at least one surveillance assessment of the agency to determine that it continues to meet the requirements of ISO and any supplementary criteria. Conditions for Recognition 10 June 2005

12 8 Verification Verification of the conditions contained in this document will be performed by accreditation and recognition bodies when assessing an agency or person and NZFSA when it receives information to support certification. If all conditions are complied with then the accreditation or recognition body provides a recommendation to NZFSA Dairy and Plants for recognition or continued recognition. If an agency or person does not comply with all conditions then no recommendation should be provided. NZFSA Compliance and Investigation Group will also assess compliance with conditions outlined in this document as part of any allocated systems audits which are part of scheduled activities. If a critical non-compliance is identified by a recognition or accreditation body or as part of an NZFSA Compliance and Investigation Group audit then recognition of an agency or person may be reviewed by NZFSA Dairy and Plants. 8.1 Laboratories If an accreditation/recognition body withdraws, suspends or changes the accreditation/recognition status of a recognised laboratory, the accreditation/recognition body advises NZFSA Compliance and Investigation Group of the change in status, and NZFSA may: cancel recognition, vary any conditions subject to which a laboratory is recognised, or impose any new or additional conditions subject to which a laboratory is recognised. The recognition of a laboratory may be cancelled or amended if: the occupier of the laboratory concerned asks the Director-General to do so; the Director-General is satisfied that the laboratory no longer has the premises, equipment, procedures and staff necessary to ensure that the testing carried out there for the purposes of the Act will be carried out properly and competently; Conditions for Recognition 11 June 2005

13 the Director-General is satisfied during the past 6 months there has been a breach of any conditions subject to which the laboratory was recognised; or the Director-General is satisfied that the occupier has failed to comply with any Compliance Order or Direction under the Act. 8.2 Test Methods If a dairy laboratory does not operate in accordance with the conditions in relation to approved test methods: A Compliance Order or Direction may be issued by an Animal Products Officer or to remedy any defects; export certification and/ or use of any NZFSA marks may be suspended; recognition of the laboratory may be cancelled or conditions varied or imposed; and/ or prosecution for offences may occur. 8.3 Recognised Agencies and Persons If an accreditation body withdraws, suspends or changes the accreditation status of a recognised agency or person, the accreditation body advises NZFSA Compliance and Investigation Group of the change in status, and NZFSA may: cancel recognition, vary any conditions subject to which an agency or person is recognised, or impose any new or additional conditions subject to which an agency or person is recognised. Recognition may be granted subject to conditions specified on the Notice of Recognition. These conditions may be revoked, amended or added to at any time by written notice, however, the conditions may not be varied without first giving the recognised agency the opportunity to make written submissions or to be heard in relation to the matter. An applicant must not perform any function or activity of a recognised agency until the Notice of Recognition has been received. Conditions for Recognition 12 June 2005

14 Every recognised agency must operate in accordance with any conditions specified by the NZFSA. The recognised agency must retain the Notice of Recognition for the duration of their recognition and make it available for audit purposes on request by an Animal Product Officer or NZFSA employee. The Notice of Recognition must be surrendered on the cessation of recognition or when required by the NZFSA. Recognition may be surrendered at any time by written notification to the NZFSA. The surrender will take effect 3 months after the notification is received or at an earlier date if agreed. The Notice of Recognition must be returned to the NZFSA by the end of the day on which the surrender takes effect. Where a recognised agency, through which a recognised person gained accreditation, ceases to be recognised or the recognised person leaves that recognised agency, then that person s recognition, in relation to that recognised agency, expires. The recognition of a agency or person may be cancelled or amended if: the agency or person concerned asks the Director-General to do so; the Director-General is satisfied that the agency or person no longer meets requirements; the Director-General is satisfied during the past 6 months there has been a breach of any conditions subject to which the agency or person was recognised; or the Director-General is satisfied that the agency or person has failed to comply with any Compliance Order or Direction under the Act. Where it is proposed to refuse recognition: the applicant will be notified in writing of this fact along with the reasons for the refusal; and the applicant will be provided with a summary of the information used to make the decision. The applicant may request a review of the proposed refusal. This request may be in the form of a written submission or the applicant may request to be heard in respect of the Conditions for Recognition 13 June 2005

15 matter. Note that the request should state the reasons why the applicant believes the proposed refusal is unjustified. Where the original proposal to refuse is upheld, the applicant will be notified of this decision in writing giving the reasons. This actual decision may in turn be reviewed. Agency recognition may be withdrawn at any time by written notice when: there was a failure to comply with a term, condition or performance criteria; or there was a failure to comply with any requirement of the Act; or the agency [or Directors] is no longer fit or proper to carry out the functions or activities for which the recognition was granted. The agency or person will have a reasonable opportunity to be heard before recognition is withdrawn. Where recognition is withdrawn, the affected party must surrender their Notice of Recognition to the NZFSA and take steps to notify all clients of the withdrawal. Where a person acting under the delegated authority of the Director-General performed the withdrawal, the affected agency may seek a review of that decision. A recognised agency that, without reasonable excuse, fails to comply with the duties set out in section 106 of the Act commits an offence. Failure to comply with the duties may result in a fine on summary conviction. Where a body corporate commits the offence, the fine may be up to $100,000. Where an individual commits the offence, the fine may be up to $25,000. A recognised person who, without reasonable excuse, fails to comply with the duties set out in section 107 of the Act, commits an offence. Failure to comply with the duties may result in a fine, not exceeding $50,000, on summary conviction. Conditions for Recognition 14 June 2005