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Dairy Products Safe and True

Part B     Standards

Validation of Environmental Pathogen Surveillance Programmes (SUPERCEDED)

1. Purpose
2. Scope
3. Definitions
4. References
5. Validation procedure
6. Responsibilities and authorities
7. Documentation and records
8. Actual practice
9. Validation report
10. Reporting to MAF Reg
11. MAF Reg actions

1.      Purpose

1.1     Each dairy manufacturer must manage the risk of pathogen contamination in dairy products by conducting HACCP assessments of the process and the product, and using good manufacturing practices and appropriate surveillance. Approved methods for these activities are in the codes listed in Section 4.

1.2     Environmental pathogen surveillance programmes monitor the manufacturing environment, the process and the product to confirm that pathogens are controlled.

1.3     Surveillance programmes are validated by assessors, recognised under MRD-Stan 1, to confirm that the programmes are properly designed and carried out. MAF RA accepts the validation reports and is able to minimise its own direct involvement in verifying control of pathogens.

1.4     This standard satisfies Regulation 9, Approvals in respect of manufacture, of the Dairy Industry Regulations 1990. Product safety programmes conforming to this standard will be approved in respect to environmental pathogen surveillance.

2. Scope

This standard indicates the areas of coverage for assessors contracted to provide validation of environmental pathogen surveillance programmes at dairy companies.

3.      Definitions

Environmental pathogen surveillance programme means those activities undertaken to assess the risk of, sample for, test for and take corrective action as a consequence of finding pathogenic organisms.

Validation means assessing the adequacy of procedures, practices and records against standards approved by MAF Reg.

Recognition means the acknowledgment by MAF RA in writing that a service or individual meets the required standard and the results of their work may be used to contribute to MAF RA monitoring.

MAF Reg means the Ministry of Agriculture Regulatory Authority - Dairy.

4.      References

• Standard MRD-Stan 1: Standard for Inspection, Audit and Approval Services.
• Dairy Industry Regulations 1990.
• ISO 10011 (NZS 10011): Guidelines for auditing quality systems.
• NZCP 5: Dairy Products Safety Standards Code of Practice.
• NZCP 8: Traceback Procedures Code of Practice.
• New Zealand Dairy Industry Pathogen Management Checklist.
• NZTM 2: Microbiological Methods Manual.
• Guidelines for the Application of the Hazard Analysis Critical Control Point (HACCP) System. Codex Alimentarius Commission. Alinorm 95/13, Annex to Appendix III.

5.      Validation Procedure

5.1     Validation shall be carried out once per year by an assessor recognised by MAF Reg for category Pe (validation of environmental pathogen surveillance programmes) under Standard MRD-Stan 1. The organisation providing the validation service shall also be recognised in category Pe.

5.2     The assessor shall use procedures based on ISO 10011, and follow the procedures laid down by the organisation providing the validation service. The assessor shall develop individualised checklists based on the standards for environmental pathogen surveillance specified in the dairy company's product safety programme (PSP), the Codex Guidelines for HACCP, and the specific circumstances at the factory being assessed. Each PSP must specify NZCP 5, NZCP 8, the New Zealand Dairy Industry Pathogen Management Checklist and NZTM 2, or alternative standards approved by MAF Reg.

5.3     Individualised checklists shall cover at least the points listed in Sections 6 to 8.

6.      Responsibilities and Authorities

The assessor shall check that responsibilities and authorities for all aspects of the environmental pathogen surveillance programme are clearly defined. In particular responsibility for the following aspects must be defined:

• overall responsibility for the programme,
• documentation system,
• implementation and maintenance,
• actions in case of level 1, 2, and 3 positive results,
• interpretation of analytical results, particularly their significance in relation to the HACCP and sampling programmes,
• actions in case of level 4 and product positive results,
• notifications to MAF RA and the New Zealand Dairy Board,
• on-going system review.

7.      Documentation and Records

The assessor shall check that the environmental pathogen surveillance programme is documented in sufficient detail to provide a good understanding of how it works, and has sufficient records to allow full traceability. The following documents are considered necessary. Note: This list is not exhaustive.

• procedures for:
  • assessing risk and determining sampling sites and frequencies using HACCP, and review of sample sites
  • sampling including technique, frequency, amount, and triggers for extended or altered sampling
  • internal audit of the sampling programme
  • review of sample sites
  • sample identification
  • sample handling, including preparation and containment of the swab diluent
  • sample despatch
  • matching results to sampling sites
  • follow-up actions in the case of positive results
  • notifications to MAF RA, New Zealand Dairy Board and health authorities where required
  • clean-up and fumigation, for elimination of pathogens
  • corrective action to prevent a recurrence
  • training those involved in implementing the procedure;
• a site plan showing specific sample sites, their identification, and their designation for nominated pathogens;
• demarcation of levels 1, 2, 3 and 4;
• sample submission forms;
• records of results;
• records of actual follow-up activities;
• training records for those involved in the surveillance programme.

8.      Actual Practice

The assessor shall check that the environmental pathogen surveillance programme is implemented and maintained in a manner that provides the company with timely information that allows corrective action to minimise the risk of product contamination. The following items are essential to the evaluation:

• history of the programme over the previous 12 months, including positives and corrective actions;
• evaluation of plant, building and process changes since the last evaluation using an HACCP approach;
• sites sampled (as per instructions, appropriate?);
• levels appropriately defined?;
• timing of sampling;
• people trained to take samples;
• sampling technique;
• sample identification;
• records of sites sampled;
• sampling equipment dedicated, appropriate, sterile?;
• sample storage;
• sample despatch;
• matching results to sampling sites;
• interpreting results;
• follow-up activities appropriate to each level?;
• elimination procedures followed;
• other corrective actions defined and implemented;
• responsibilities clear?;
• product testing as per requirements of NZCP 5?;
• traceback activities;
• notifications/reporting.

9.      Validation Report

9.1     The assessor shall prepare a validation report for the dairy company as required by MRD-Stan 1.

9.2     The report shall include the following:

• a summary of positive results since the last evaluation;
• a summary of plant, building, and process changes since the last evaluation;
• a list of documents evaluated during the validation process;
• a list of non-compliances with the approved PSP;
• recommendations for improvement.

10. Reporting to MAF Reg

The organisation being assessed shall supply MAF Reg with a copy of the report and the actions proposed to address any non-compliances.

11. MAF Reg Actions

11.1     MAF Reg will approve an environmental pathogen surveillance programme that contains the provisions detailed in Sections 5 to 10.

11.2     MAF Reg may take the following actions, as appropriate, if the standard is not fully complied with:

• make additional visits to obtain or verify information;
• require reports to be provided directly by inspection agencies;
• direct that the environmental pathogen surveillance programme be validated by a MAF Reg-recognised auditor;
• decline to supply MAF export certificates, and withdraw permission for the use of any MAF mark;
• take other action as provided under the Dairy Industry Act 1952 and Regulations.

Revision Status
Rev	Date	Status	By	Approved
1	14 December 1995	Issued for use	Chief Dairy Officer

Amendment and Control Procedure

Amendments to this standard will be issued to holders of Dairy Products Safe and True, and to the MAF RA address list for circulars and newsletters. Suggestions for improvements to this standard are welcomed. They should be sent to: The Chief Dairy Officer MAF Regulatory Authority P.O. Box 2526 Wellington