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Regulated Control Scheme for Limited Processing Fishing Vessels: Operator Guidelines

Part 2: Development of an Operator Documented System

Amendment 0

September 2004

For each registered vessel, the operator must develop and implement an operator documented system, based on Hazard Analysis and Critical Control Point (HACCP) principles and in accordance with regulation 39 of the RCS Regulations 2001. In most cases where supporting systems are largely used to control and manage identified hazards, a hazard identification process is sufficient. If supporting systems are not able to control and manage all identified hazards, the operator must develop a HACCP plan (see RCS regulation 40).

An operator's documented control system will be legally binding for the vessel registered under the RCS. The fishing vessel must operate according to the programmes described by the operator documented system.

Where necessary, operators should seek external assistance to develop their operator documented system(s).

2.1 Contents of the Documented Control System

The operator or the person responsible for day-to day management must sight the operator documented system and must sign the cover sheet of the operator documented system.

Under the Animal Products Act 1999, the fishing vessel operator has the ultimate responsibility for ensuring that the operator documented system is effectively implemented. The operator must also document who is responsible for the day-to-day management of the vessel and the processing operations, and consider documenting how a deputy is assigned to cover for shifts.

The components of the operator documented system are shown in Figure 2A.

Figure 2A: Components of the Operator Documented System

2.2 Identification and Control of Hazards

A key requirement under the RCS is to identify hazards that are reasonably likely to occur during the processing of fish or fish products intended for human consumption [see RCS regulation 40(1)(a)]. The hazard identification may be required for processes applicable to other products, if required by specifications [see regulation 40(1)(b)]. During this procedure, the operator must consider the hazards associated with raw material and other inputs, with process steps, and with other sources.

The main categories of hazards to be addressed are shown in Table 2.1.

Table 2.1: Categories of Hazards and Risk Factors

Hazards RCS Regulation 40(2)	Hazards to human health Hazards to animal health (optional at present) Risks that are reasonably likely to occur from false or misleading labelling; and Risks that are reasonably likely to occur to the wholesomeness of the fish material or product.
New Hazards (Clause 48 of the RCS Specifications)	Operators must notify new hazards (emerging, new or exotic biological, new chemical) that come to their notice to the Director, Animal Products, without delay.

The hazard identification and analysis are based on HACCP principles, which have for some time been used by the seafood industry to control food safety hazards in their processes. The hazard identification and analysis procedure must be incorporated into the operator documented system to demonstrate that hazards to human health are under control. Other risk factors, e.g.: risks to the wholesomeness of the fish material or fish product and risks due to misleading labelling, should be considered and may be included in the operator documented programme if appropriate.

Before identifying hazards, the operator should ensure that the supporting systems are documented and confirmed as effective. For limited processing fishing vessels, the control of hazards is achieved mainly by the proper functioning of the supporting systems unless the operator documented system shows otherwise.

Where a food safety hazard is identified and no adequate control measure exists in the supporting systems, the operator must develop a HACCP plan.

A hazard may remain unaddressed by the process. Such hazards should be identified as uncontrolled hazards (e.g.: parasites in chilled fish, mercury content in certain types of fish meal).

A guideline on the application of HACCP to the seafood industry is available on the NZFSA web site at: www.nzfsa.govt.nz/animalproducts/seafood/guidelines/haccp/

The following Figure summarises the process to be followed in the hazard identification.

Figure 2B: Hazard identification process

2.3 Supporting Systems

It is practical and appropriate to manage some sources of hazards, or the hazards themselves, independent of the process. The systems used for this purpose are referred to as supporting systems (e.g.: prerequisite programmes, good hygienic practice). Supporting systems may interact at a number of process steps both within and across various processes.

A list of supporting systems used in the control of hazards should be included in the operator documented system. These systems should meet the relevant requirements in the RCS specifications.

The operator documented system should also designate the person or persons responsible for the day-to-day management of each supporting system, and state the type and frequency of monitoring activities required.

Examples:

1. The cleaning and sanitation programme should identify:

• the person responsible for the overall programme;

• the specifications or standards adhered to;

• the frequency and locations of visual checks, and any other monitoring procedure performed to confirm the effectiveness of the programme; and

• corrective action procedures in case of failure.

2. The water management plan should identify:

• the person responsible for the overall management of the plan;

• any specifications or standards adhered to;

• procedures, including management of supplier guarantees and frequency of review of those guarantees¹;

• monitoring activities, including visual tests and inspection at specified locations;

• any other testing, including physical examination carried out; and

• corrective action procedure in place in case of failure.

Other examples of supporting systems that are relevant to limited processing fishing vessels are:

• Sanitary design and essential services

• Design and construction

• Facilities

• Water

• Vermin control

• Amenities

• Processing gases

• Premises hygiene and maintenance:

• Waste management

• Management of chemical compounds

• Personnel hygiene

• Competency of personnel and training programmes

• Labelling

• Traceability and recall procedures

• Calibration

• Maintenance of records and documentation

2.4 Operational Authorities and Responsibilities

There are no specific competency requirements in the RCS, but the operator must provide appropriate instruction and supervision of staff.

Operational authorities and responsibilities must be documented at appropriate places within the operator documented system (in any format that suits the operation). In other words, the operator must describe who is responsible for carrying out the tasks required to implement the operator documented system, including:

• monitoring activities;

• corrective action activities;

• operator verification activities;

• recall of non-complying product.

In some vessel operations, the operator may delegate these responsibilities and authorities to different people at different times, depending on availability of personnel e.g.: by roster. In such cases, the operator must document the method for delegating responsibilities and authorities.

Responsibilities can be documented either by name, position or designation. In order to minimise the updates to the operator documented system, it is recommended that the position or designation option is used.

Table 2.2: Activities for which authorities and responsibilities should be identified

Authorities and responsibilities	Clarification
Monitoring activities (used for operator verification, validation)	Including: • Observations; • Inspection; • Testing.
Corrective action activities	Including: • Restoration of control; • Control and disposition of non conforming product; • Possible re-working of non-conforming product; • Prevention of recurrence; • Recall of non-conforming product.

2.5 Provision for Verification Activities and Verifier’s Rights

The description of the arrangements and procedures made to enable accredited verifier activities is an important component of the operator documented system. These requirements are described in clause 53 of the RCS specifications and include:

• providing access to the processing areas of the vessel;

• providing access to records, documentation and information relating to the operator documented system (including electronic records);

• freedom for verifiers to examine and to open any container, packaging and to inspect contents and associated things; and

• freedom for verifiers to identify, mark, examine, sample, test and analyse relevant materials.

Accredited verifiers are also authorised to detain any product or associated thing, and to intervene or temporarily interrupt processing if necessary, as described in clause 53 of the RCS specifications.

2.6 Documentation and Record Keeping Requirements

All components of the operator documented system must be documented in writing² and be legible. The operator should ensure that all information in the operator documented system is presented in a format that facilitates process/operational control and operator verification activities, including validation by the operator prior to registration.

The RCS allows operators some flexibility in the way they record the operator documented system. The operator documented system can reference recognised codes of practice, hazard identification or other relevant documented procedures in part or in full, rather than include entire documents. Any such references then become part of the operator documented control system. However, any sections of those documents that are not specifically referenced do not form part of the operator documented system.

All documentation relevant to the operator documented system must be readily accessible to the verifiers and regulators, as necessary. The correct version and dates (year, month and day) of the referenced documents must be included in the operator documented system summary.

2.7 Operator Verification of the Operator Documented System

The operator documented system must specify the procedures for operator verification to determine that requirements of the RCS have been met.

2.7.1 Operator validation of the operator documented system

The following can be used to validate the operator documented system:

• historical data/records

• records demonstrating compliance

• adherence to recognised codes of practice and guidelines (e.g.: IAISs).

Validation involves the collection of information and its analysis. This information is commonly obtained using analytical testing, visual observation and inspection equipment.

Visual observation is generally used for inspecting products for visible defects (e.g.: cleanliness of surfaces, spoilage of fish material or fish product) and the presence of visible contaminants (e.g.: foreign objects). It is also appropriate to use visual observation when observing compliance with established procedures, e.g.: for personnel hygiene practices, manual operations.

In some cases visual observation, rather than analytical testing, may be a more practical and economical means for evaluating the adequacy of certain procedures. Records of these visual observations can be used for validation. It is important that observers are adequately trained and procedures are standardised to ensure accurate and consistent results.

Inspection equipment, such as metal detectors, may be used for detecting specific physical contaminants (e.g.: metal, glass) during in-line inspection of raw materials and products.

2.7.2 Ongoing operator verification

Ongoing operator verification activities may include but are not limited to:

• internal audits;

• calibration checks;

• review of monitoring records;

• tests; and

• review of non-conformance and corrective action records.

The frequency of the above activities may be based on performance and will vary according to the part of the operator documented system being verified. The initial frequency used for verification of control of hazards may be reduced if defined parameters are consistently met and results systematically recorded. Flexibility is left with the operator unless otherwise stipulated by a mandatory requirement. As part of the operator verification procedures within the operator-documented system, the operator should document how ongoing operator verification activities will be established, by whom, and where the current frequency is recorded.

2.8 Amendments to the Operator Documented System

The operator should record any changes to the operator documented system where these changes mean that the operator documented system:

• is no longer appropriate, or will no longer be appropriate to the fish material or product, processes, or area covered; or

• will impact on the fitness for intended purpose of the fish material or fish product concerned.

The operator should document these changes, confirm their validity where necessary and bring them to the attention of the accredited verifier during the next scheduled verification.

2.9 Operator Documented Systems in Conflict with Regulations or Specification

Where there is any conflict between documented requirements of an operator documented system and requirements of regulations or specifications made under the RCS, e.g.: by failure to amend or update as required, the requirements of the regulations or specifications will prevail.

¹ The supplier guarantees for potable water should be renewed every year. The Director, Animal Products will authorise further testing of water (for requirements given in Schedule 1 and the definition of potable water in the RCS specifications) if considered necessary by the external verifier.

² In writing means printed, typewritten, or otherwise visibly represented, copied, or reproduced, including by fax or email or other electronic means.