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Code of Practice: Processing of Bee Products

10 Document Control and Record Keeping

Amendment 2

June 2006

10.1 Purpose and scope

To ensure that all RMP documents, including records, are managed under a document control system that meets the requirements of the Animal Products Act 1999.

10.2 Mandatory requirements

10.2.1 AP Reg 18(1)

All operators of risk management programmes, all exporters, and all other categories of person required by specifications to do so, must have a tracking system that:

a. allows for the identification of bee products; and

b. enables the movement of the bee products to be traced--

i. where required by specifications, from the origin, through the supplier and the operator's business premises to the next recipient of the bee products; or

ii. where specifications do not require tracing from origin, from the supplier and the operator's business premises to the next recipient of the bee products.

10.2.2 RMP Spec 16 (1)

Every document or part of a document that forms part of a risk management programme must be:

a. legible;

b. dated or marked to identify its version;

c. authorised prior to use, either directly or within the document control system, by:

i. the operator,

ii. the day-to-day manager of the programme, or

iii. a person nominated to do so in the programme’s document control system; and

d. available when required to any person with responsibilities under the programme.

10.2.3 RMP Spec 16 (2)

The operator must document the procedures for effective document control of the documents that form the risk management programme including how:

a. significant and minor amendments are made to the risk management programme so that the programme is current and reflects the actual operation;

b. the amendments, or the nature of the amendments to the programme are identified or described; and

c. documents are authorised prior to issue and use; and

d. all amended parts of the risk management programme are replaced with the current versions at all distribution points without unnecessary delay after authorisation and, where necessary, registration in accordance with section 25 of the Act.

10.2.4 RMP Spec 16(3)

The operator must retain for four years, one copy of all obsolete documents from a registered risk management programme in a manner that protects the documents from damage, deterioration or loss, and prevents confusion with current documents.

10.2.5 RMP Spec 16(4)

The operator must ensure that the registered risk management programme and all reference material relating to the risk management programme, and any archived documents are readily accessible, or can be retrieved and made available within two working days of any request to:

a. accredited persons (now called recognised persons); and

b. animal product officers; and

c. the Director-General; and

d. persons authorised by the Director-General.

10.2.6 RMP Spec 17 (1)

The operator must include record keeping procedures in the risk management programme to ensure that all records necessary to demonstrate compliance with the documented programme are legible, stored for four years in a manner which protects the records from damage, deterioration or loss and can be retrieved and made available to persons defined in clause 17(3) within two working days of any request.

10.2.7 RMP Spec 17(2)

Records relating to the risk management programme’s monitoring, corrective action and operator verification activities must include:

a. the date and time of the activity;

b. a description of the results of the activity; and

c. a means to identify the person(s) who performed the activity.

10.2.8 RMP Spec 17(3)

The operator must make all records relevant to the risk management programme available to the following persons as required:

a. accredited persons (now called recognised persons);

b. animal product officers;

c. the Director-General; and

d. persons authorised by the Director-General.

10.2.9 HC Spec 34 (3)

An inventory control programme must be documented for animal material and product and records maintained.

10.3 Procedures

10.3.1 Record keeping

10.3.1.1 All relevant GMP and processing records must be kept, including inventories of raw materials and finished products.

10.3.1.2 All relevant electronic records must be backed up and protected from corruption, damage or loss.

10.3.1.3 Records must include the date and the signature of the responsible personnel. In the case of electronic records compiled by personnel, the person entering the data must be identified according to systems developed for the protection of electronic records.

10.3.2 Inventories

10.3.2.1 Inventories must be maintained for all raw materials (e.g. incoming honey) and finished products.

10.3.2.2 Non-complying products and the reasons for non-compliance must be clearly identified in the inventory.

10.3.2.3 There must be a system in place for the identification of raw materials and products, and documentation that will allow any finished product to be traced:

• back to the supplier and the apiaries that the bee product was sourced from; and

• to the next person or company that the product is transferred to for further processing, packing, or storage; distributed to; or sold to.

10.4 Records

All records must be kept by the operator including:

• GMP compliance records

• processing records

• inventories