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Dairy Products Safe and True

Part B     Standards

MRD Standard 6

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Standard Procedure for Auditing Dairy Product Safety, and Guidelines for an Audit Checklist(Superceded)

1. Purpose
2. Scope
3. Standards for Dairy Product Safety
4. The Auditing Agency
5. The Auditor
6. Preparation for Audit and Product Safety
7. Checklist Items
8. Reporting

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1.     Purpose

This is a standard for the audit and audit reporting of product safety at dairy factories, milk stations, stores and depots, and guidelines for an audit checklist.

2.     Scope

This standard applies when a dairy company has engaged an audit agency to carry out an audit that includes product safety, and the audit information is intended to be used by MAF Reg. The standard is additional to the requirements of MRD-Stan 1. These requirements apply only to product safety for the purposes of the Dairy Industry Regulations 1990 and MAF product certification.

3.     Standards for Dairy Product Safety

The audit shall use the following standards for dairy product safety as appropriate:

• the Dairy Industry Act 1952,
• the Dairy Industry Regulations 1990,
• the Food Act 1982,
• the Food Regulations 1984,
• the Food Hygiene Regulations 1974,
• MRD-Stan 1: Standard for Inspection, Audit and Approval Services,
• MRD-Stan 2: Standard for Reporting Information to MAF Regulatory Authority,
• MRD-Stan 4: Standard for Checking the Operation of Pasteurisers,
• Dairy Board specifications,
• manuals and codes approved by MAF Reg circulars and referenced by the company's approved product safety programme (PSP).

4.     The Auditing Agency

The auditing agency shall be recognised by MAF Reg for "dairy product manufacturing audit". It shall have a management system which meets the standards of ISO 10011 (NZS 10011: Guidelines for auditing quality systems) and EN 45012 (BS 7512: General criteria for certification bodies operating quality system certification). In particular the agency shall:

• have procedures to select, train, monitor and update the skills of its auditors;
• have procedures and work instructions that make it clear what is expected of the auditor;
• ensure that the auditor is familiar with the legislation, industry standards and codes, and this standard.

5.     The Auditor

5.1     The member of the audit team who audits product safety shall be recognised by MAF Reg specifically for "dairy product manufacturing audit".

5.2     To qualify for recognition, the product safety auditor shall have the appropriate background, qualifications, specific training, and experience in the role they are undertaking, i.e. they should have participated in audits under the supervision of a recognised auditor, and they should be technically competent in the areas which the audit covers (for example milk production, dairy manufacture, etc.).

5.3     The product safety auditor must be able to form a comprehensive overview of safety.

5.2     The product safety auditor must be independent of the company being audited, and not directly providing inspection or testing services to the company.

6. Preparation for Audit of Product Safety

6.1     Auditors shall be briefed before the audit, and shall have access to the documented product safety programme, with sufficient time to compile a checklist based on these guidelines before the audit.

6.2     The auditor shall prepare a detailed audit checklist, specific to the area beng audited, directly from the references listed in Section 3, paying particular attention to good manufacturing practice and product safety, and from any other information received since the previous audit. The auditor shall also take account of the procedures for pasteuriser checking, pest management, pathogen surveillance, and farm dairy and factory inspection.

6.3     The audit agency shall inform the auditee if a MAF Reg observer is to be present, and obtain permission to allow MAF Reg access to information on product safety generated during the audit.

7.     Checklist Items

The following items shall be included in the audit checklist.

7.1     Follow up from the last audit

Follow up unresolved non-compliances and corrective actions from the previous audit or visit.

7.2     Product safety programme

Has it been approved by MAF Reg? Does it cover all operations? Are there any attached conditions? Is the PSP available and known by appropriate staff?

7.3     Standards

Are the food safety standards, codes of practice, acts, regulations, specifications, etc., available and known by appropriate staff?

7.4     Registration of premises

Are all premises covered by appropriate registration certificates?

7.5     Alterations to premises and maintenance

Have all alterations to the premises or equipment that might affect the hygienic status of the premises or jeopardise product safety been notified to MAF Reg prior to commencement of work?

Have alterations received timely review (at design, construction, commissioning, pre-start) by competent people?

Were these reviewers recognised by MAF Reg?

Were corrective actions undertaken, timely, and followed up by the reviewer?

Was MAF Reg notified of the outcome of these checks? Was the registration updated?

Are there maintenance procedures and records of breakdowns? Are there procedures for intrusive maintenance? Are spares for items that are critical to product safety available?

7.6      Farm dairy inspections

Is there a current record of all supplying farm dairies, with their address and the name of the operator or owner? Were these inspected?

Were the inspectors and the inspection agency MAF Reg recognised?

Were corrective actions (short and long term) undertaken, timely, and followed up by the inspector?

How do the suppliers know the inspection standard?

7.7     Farm dairy approvals

Were these done?

Were the approvers and the approval agency MAF Reg recognised?

Were corrective actions undertaken, timely, and followed up by the inspector?

How do the suppliers know the design standards?

7.8     Tanker inspections

When were these done?

Were the inspectors and the inspection agency MAF Reg recognised?

Were corrective actions undertaken, timely, and followed up by the inspector?

7.9     Raw milk quality

Is there a standard for saleable or safe milk (which excludes milk from diseased animals, impure, tainted or contaminated milk, abnormal milk, colostrum milk, etc.)? Is there a procedure for identifying unsaleable or unsafe milk before collection? Is it known to the people responsible (e.g. tanker drivers)?

Was there milk that failed this standard? What happened to the milk? Was it disposed of safely and appropriately so as not to endanger people or animals? Were the corrective actions timely and appropriate? Were they reported to MAF Reg?

Were milk supplies sampled, tested and graded according to the product safety programme? Is the laboratory registered?

Were the grades correctly allocated? Were corrective actions undetaken, timely, and followed up by an inspector?

7.10     Factory inspections

When were these done? Were all the following items included?

• calibration,
• pest management details,
• pasteuriser details,
• process control,
• equipment design, installation and operation, and alterations,
• metal detectors,
• sieves and filters,
• magnets,
• air filters and ventilation systems,
• services for steam air and water,
• CIP systems,
• raw milk storage,
• building design and upkeep, and alterations,
• staff amenities,
• sampling of product,
• laboratory tests and procedures,
• rubbish disposal,
• actual control of people (staff and visitors), etc.

Are the process flow diagrams (manufacture and CIP) adequate (complete, up to date), used, reviewed and amended?

Were the inspectors and the inspection agency MAF Reg recognised?

Were corrective actions (short and long term) undertaken, timely, and followed up by the inspector?

7.11     Store inspections (including milk depots)

When were these done?

Were the inspectors and the inspection agency MAF Reg recognised?

Were corrective actions undertaken, timely, and followed up by the inspector?

7.12     Laboratory certification

Has the laboratory been certified by a MAF Reg recognised body? When was it audited? Was it within 12 months of the previous audit? Were the auditors recognised by MAF Reg?

Did the audit cover all laboratories, including rationalised testing laboratories, process laboratories, raw milk testing laboratories?

Are all product safety tests and hygiene indicator tests included in the accreditation?

7.13     Audit samples

Were all the audit samples taken and tested? Were the samples taken and tested independently of the company? Were the independent laboratories registered by MAF Reg?

Were the results compared to the company laboratory results? Were corrective actions undertaken and timely?

7.14     Pathogen surveillance and hygiene monitoring

Is the environmental surveillance programme independently reviewed and endorsed?

Are the reviewers recognised by MAF Reg?

Has all product been tested for pathogens as per specification?

Have all environmental samples been taken and tested?

Is there a documented traceback system? Was it activated appropriately?

Are there CIP and cleaning swab checks, yeast and mould air counts, and in process testing at intermediate stages before grading of the final product?

7.15     Staff health and hygiene

Are there documented rules for staff health, sickness, training, clothing, entries to premises, record keeping?

Are these rules publicised, known by staff, applied to visitors?

7.16     Pest management

Is there a documented pest management programme covering at least rodents, birds and insects?

Has the programme been independently reviewed and endorsed? Are the reviewers recognised by MAF Reg?

7.17     Heat treatment

Are the heat treatments given to each product known?

Are they sufficient to kill pathogens? Do pasteurisation heat treatments satisfy MRD-Stan 3?

Are pasteurisers independently verified as reliable according to MRD-Stan 4? Are the providers of this service recognised by MAF Reg? Were corrective actions undertaken, timely, and followed up by the checker?

7.18     Records

Are process and product testing records accessible and kept securely for at least the life of the product, and not less than 2 years?

7.19     Ingredients and processing aids

Are these purchased to edible specifications?

Is evidence of conformance to specification available with incoming ingredients?

Are only accepted ingredients used? Are ingredients stored to prevent contamination?

7.20     Traceability

Are all ingredients, substances with incidental food contact, process aids, packaging, etc, traceable from the product back to source?

Is all product traceable back to raw materials?

7.21     Product quality

Are there standards and sampling frequencies for product (based on, for example, NZDB specifications, NZCP 5, the Food Regulations, etc.)? Was product sampled and tested to these standards?

Was there product that was nonconforming? Was this product declared unsafe if it failed safety standards? Was it identified so as to be traceable?

What happened to this product (reworked, reconstituted, recycled, reblended, withdrawn from the NZDB product acquisition system, sold to someone, dumped, still in store, etc.)? Was the product disposed of safely and appropriately so as not to endanger people or animals? Was the disposition approved, prior to disposition?

Were the corrective actions timely and appropriate?

Was it reported to MAF Reg at the time as per MRD-Stan 2?

Are there documented procedures for hold, retest, traceback, recall and product disposition? Are they followed?

If there was nonconforming product, were there instances when conforming product was treated as if it was nonconforming (i.e. withdrawn from the NZ Dairy Board product acquisition system, dumped, sold as stockfood, etc.)? In these cases were the procedures for hold, retest, traceback, recall or disposition followed? (This check tries to find out what might happen if they actually made some unsafe product.)

Are there documented rules for resampling, retesting, changing of grade or quality code, for product originally downgraded? Are these in the product safety programme?

Are these rules appropriate? Are they followed?

What happens to product which is declared unsafe or unfit as a result of in-process testing (before final product testing)?

Is there a system for checking that grades and quality codes are correctly allocated?

Do procedures for controlling the use of the MAF "Approved for Export" mark conform to NZ Dairy Board product procedures and specification manuals?

Are all packages of dairy products manufactured (including blending and packing) in the factory clearly marked with the factory's own registered number, and no other number? Is marked packaging used for no other purpose?

7.22     Complaints

Are complaints relating to product safety recorded?

Is corrective action timely and appropriate?

Was it reported to MAF Reg at the time as per MRD-Stan 2?

7.23     Reporting to MAF Reg

Was reporting as per MRD-Stan 2 (using any extra information gained during the audit, especially from Paragraphs 7.21 and 7.22)?

7.24     Internal and external checks

Are there daily, or routine, housekeeping checks of equipment, premises, tools? Are tasks, procedures and internal audits documented?

What are the results of other external audits and inspections (by customers, ISO system auditors, local health authorities, consultants, etc.)?

8.     Reporting

The audit agency shall supply the company with its audit report containing information about the aspects of dairy product safety and integrity audited, confirming compliance as well as reporting noncompliances. The information about the safety and integrity audit should be separate or separable from other sections of the audit report so that it is easily made available to MAF Reg by the company.

Revision Status
Rev	Date	Status	By	Approved
2	11 March 1994	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 Reg 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