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Risk Management Programme Manual for Animal Product Processing

3 RMP Development

Amendment 3

October 2009

3.1 Introduction

(Section 17 of the Animal Products Act)

This section provides guidance on designing an RMP.

3.1.1 RMP Development Expertise

Understanding the application of HACCP principles is essential to develop and implement an RMP. If this expertise is not available in-house, NZSFA recommends that competent external advice is sought, or a member of staff undertakes appropriate training. A team approach offers the benefit of a range of expertise, different perspectives and experience. The members of this team should be selected on the basis of their responsibilities, knowledge and experience of the products, processes and hazards relevant to the scope of the RMP, and knowledge of the principles and practice of producing food safely.

3.1.2 RMP Development Time

If you want to register an RMP by a certain date, it is your responsibility to allow sufficient time for development, evaluation and registration. The time necessary will depend on the complexity and size of your operation and the extent and suitability of existing documentation.

3.1.3 RMP Components

The RMP should include those components shown in Figure 3A that are appropriate to the product and operation. Components must be documented in writing.

Figure 3A: Components of an RMP

Component	Section Reference:
Operator, Business and RMP Identification	3.2
List of RMP Documents	3.3
Management Authorities and Responsibilities	3.4
Scope of the RMP	3.5
Animal Material and Animal Product Description4	3.6
Process Description	3.7
Good Operating Practice / Supporting Systems	3.8
Application of HACCP (Identification, analysis and control of Hazards to Human or Animal Health)	3.9
Identification and Control of Risks to Wholesomeness	3.10
Identification and Control of Risks from False and Misleading Labelling	3.11
Identification and Competencies of Responsible Persons	3.12
Corrective Action For Unforeseen Circumstances	3.13
Recall Procedures	3.14
Validation	3.15
Operator Verification	3.16
Notification Requirements	3.17
Provision for Verification Activities & Verifier Rights	3.18
Document Control	3.19
Requirements for Records	3.20
Dual Operator Butchers – extra requirements	3.21

Each of these components is discussed in succeeding sections.

3.2 Operator, Business and RMP Identification

3.2.1 RMP Operator

(Section 17 of the Animal Products Act)

Your RMP must specify the name and address (including the electronic address, if available) of the operator. The operator may be a company, a partnership or a sole trader. If the operator is a company, then the name must exactly match the details given at the Companies Office. If the operator is a partnership or a sole trader then the name(s) of the business owner(s) must be given.

You, the operator, have the ultimate responsibility for ensuring that the RMP is effective. You, or the business itself must be resident in New Zealand as defined in section OE1 or OE2 of the Income Tax Act 1994, and you, together with business directors and managers must be fit and proper persons ⁵ to operate an animal product business.

3.2.2 Businesses Covered by the RMP

The name(s) of the business(es) or part-businesses covered under the RMP must be given in their legally correct form. Where there is only one business under the RMP and the business details have already been given as part of the operator details (see section 3.2.1) then no further information is required.

If the business is a company, then the name must exactly match the details given at the Companies Office. If the business is a partnership or a sole trader operation then the name(s) of the business owner(s) must be provided. If the business trades under another name, this must also be provided.

3.2.3 Business Identifier

A unique business identifier is needed for each premises or physical location that the RMP applies to.

• The identifier must be a number or number/letter combination of at least 3 and not more than 10 characters ⁶ with at least one character as a number and no leading zeros. The business identifier must not be the same as any exporter’s registration number. You should also consider overseas market access requirements when selecting your business identifier, e.g. EU-listed premises must have individual business identifiers for each premises. Where appropriate, the business identifier will be used by NZFSA for country listing purposes and may be used by you for animal product labelling and identification.

• For multi-business RMPs, you may provide alternative details instead of giving an identifier for each business, premises or place. The alternative used must be approved by NZFSA.

In relation to exports, any change to an identifier must be reflected in updated packaging and country listings. Certain country listings may take 6 - 12 weeks to update, therefore any product produced under the RMP with a new ID may not be eligible for export to the affected countries until country listings have been updated. Once your business ID has been established, it will be used for any future RMP registration applications.

You can check availability of identifiers on the list of registered RMPs at the following links⁷:

http://www.nzfsa.govt.nz/animalproducts/registers-lists/risk-management-programmes/index.htm (non dairy)

or

http://www.nzfsa.govt.nz/dairy/registers-lists/rmp.htm (dairy)

3.2.4 RMP Number (Non-dairy only)

You may operate one or more RMPs under a business identifier. Non-dairy operators should assign a consecutive two digit RMP number (01-99), to each new RMP. Any amendments to the RMP will need to be identified using the appropriate RMP number to ensure traceability.

3.2.5 RMP Identifiers

For dairy operators the RMP Identifier is the Business Identifier. For non-dairy operators the RMP Identifier is a combination of the Business Identifier and RMP Number.

A unique RMP identifier is to be applied to each RMP (see Table 3B for an example). The unique RMP identifier will appear on the registration documentation for the RMP.

3.2.6 Unique Location Identifier (Dairy only)

For the purposes of traceability and certification, you must nominate a unique identifier for each location specified in the RMP. The unique location identifier (ULI) will appear on the registration documentation for each registered RMP. If the RMP only covers processing at one location the ULI can be the same as the RMP identifier.

You can check the availability of Unique Location Identifiers at: http://www.nzfsa.govt.nz/dairy/registers-lists/reg-fac.htm or http://www.nzfsa.govt.nz/dairy/registers-lists/reg-sto.htm

Table 3B: Examples of Identifiers

Business Identifier	RMP Number	Unique Location Identifier (ULI)
BUS111	01	000
BUS111	02	001
BUS111	03	002

3.2.7 Operator, Business and Programme Identification

NZFSA recommends that information covered in section 3.2 is located at the start of the RMP. Figure 3C gives an example of one way that this information may be presented.

Figure 3C: Example of RMP Details

Business Identifier: RMP No (non dairy only): Unique Location Identifier/s (dairy only): Name of Operator: Postal Address of Operator: Physical Address of Operator: Electronic Address of Operator: Name of Business (if different to operator): Address of Business (if different to operator):

3.3 List of RMP Documents

You must develop list(s) of all the documents that make up the RMP, including the components shown in Figure 3A. The list(s) should include supporting systems, procedures, site plans, letters confirming that external verification services will be provided, and blank record forms and any referenced documents. It is not sufficient to name the RMP as a single document without providing further detail.

It is recommended that the list(s) be located at the start of the RMP to make it easy to find the various components. A contents page may be used to meet this requirement (if sufficient details are included). Table 3D gives an example of one way to format a document list.

Table 3D: Example of an RMP Document List

					Only for multi-businesses
Document Title	Section Number	Section Title	No of Pages	Version - Date	Businesses it Applies to
Manual A Supporting Systems	3	Cleaning and Sanitation.	10	1 - 2/3/08	All
Manual B					E only
Manual C					All but E

Where only parts of a document are included in the RMP, you should clearly show which parts are included and which are not. This needs to be shown in the RMP document list by referencing those parts of the document that are included or excluded (whichever is easiest).

3.4 Management Authorities and Responsibilities

(Sections 19(a), 19(b), 22(1) (b) and 22(1) (c) of the Animal Products Act)

3.4.1 Day-to-day Manager of the RMP

You must nominate a person who is responsible for the day-to-day management of the RMP by name, position or designation. This is the person who:

• is the authorised “management representative” for all aspects of the RMP

• will deal with NZFSA over any RMP issues.

This person may be the operator, a senior operational manager, a quality/technical manager or person with similar competencies, authorities and responsibilities.

The day-to-day manager must ensure that:

• the RMP is appropriate, complete, complies with legal requirements, and is implemented as written

• significant amendments are made and registered in accordance with section 25 of the Act; and

• notifications and minor amendments are made, as appropriate.

It is acceptable to have more than one day-to-day manager provided their areas of responsibility are clearly documented in the RMP.

NZFSA recommends that you also identify a back-up person and document how this person is assigned to cover during periods when the day-to-day manager is unavailable.

NZFSA must be notified when the day-to-day manager is changed (see section 6.8.2).

3.4.2 Evidence of Sufficient Control and Consent for a Multi-business RMP

(Section 17A of the Animal Products Act)

For multi-business RMPs, you must provide evidence that your operation has sufficient control over the other businesses or part-businesses that it covers, and that you have the consent of those business owners. Examples of possible evidence include:

• a signed contract

• written correspondence between the parties.

3.5 Scope of the RMP

(Sections 12 (3) and 12 (4) of the Animal Products Act)

The scope describes what is included in, and where necessary what is excluded from, an RMP. You should consider the physical and operational aspects of the RMP when determining your RMP configuration (see section 1.6).

3.5.1 Physical Boundaries

The physical boundaries are one of the main determinants of the scope of your RMP. You must include all aspects of the operation (e.g. facilities, equipment, worker amenities, external environment, processing, storage and support areas) even those not routinely used, in the physical boundaries.

You can show the physical boundaries in a diagram or site plan of the premises, mobile premises or vessel. Wherever possible, this should be drawn to scale and should have a level of detail so that any changes to the boundary can be readily identified.

For multi-business RMPs, you may provide alternative details instead of providing physical boundaries for each business, premises or place it agreed with NZFSA. For example, multiple farm dairies operating under a single RMP may have their physical boundaries identified by the operator by assigning an identifier that is specific to each farm dairy and recording its location or address on a register.

If you operate a mobile premises you should show the physical boundaries using a diagram or plan of the vehicle. Ensuring the provision of all appropriate facilities at all sites where the premises operates remains your responsibility.

Transport operators can meet the requirement to provide the physical boundaries by maintaining an up-to-date list of the vehicles covered by the RMP.

3.5.2 Clarification of RMP Scope

(Section 13 of the Animal Products Act)

Only foods containing animal products can be regulated under the APA. Other foods must be regulated under:

• a FSP under the Food Act 1981; or

• the Food Hygiene Regulations 1974 (also under the Food Act).

3.5.2.1 Exclusions

You must document:

• any animal material, animal product or food excluded from your RMP

• the alternative regime under which they are regulated, e.g. another RMP, Food Act regime, ACVM Act regime or Medicines Act 1981

• how you will manage the interfaces between the regimes.

When explaining how the interfaces are managed you should clarify:

• the extent of the operation that is under each regime, e.g. by describing the point at which the process changes regimes, rooms used under the different regimes etc; and

• how other operations impact on the RMP, e.g. shared facilities and equipment.

3.5.2.2 Shared facilities

If your RMP includes shared facilities, you must document:

• the activities taking place that are not covered by the RMP and the times when these activities occur

• who is responsible for these activities

• how the interfaces are managed, e.g. by complete cleaning, physical separation etc; and

• the authorities and accountabilities for resolving issues associated with that activity, e.g. a contract stating who is responsible for maintaining specific buildings or equipment, how issues are raised and the time frames for satisfactory resolution etc.

3.6 Animal Material and Animal Product Description

(Section 17(1) (c) and 17(2) (c) of the Animal Products Act)

Your RMP must include a description of the animal material and animal product to which it applies. An example of how this information may be presented is given in table 3E (see section 3.6.6).

3.6.1 Animal Material or Product entering or leaving RMP

All of the animal materials or animal products entering or leaving the RMP must be documented including those intended for human consumption, animal consumption, industrial use and waste.

They may be described individually or in groups in a manner that will not compromise the identification and analysis of hazards and other risk factors. Grouping is normally based on having similar inputs, process steps and intended purpose.

The name or type of animal materials or animal products required under Clause 6(2) of the RMP spec can be addressed by using a descriptor of the product such as raw, cooked, fermented, dried, canned, smoked, frozen, chilled etc.

3.6.2 Intended Purpose

3.6.2.1 Intended consumer ⁸

You must document the intended use of the animal material or animal product and if appropriate identify any specific consumer groups e.g:

• human consumption: infants, elderly, immuno-compromised individuals (YOPI)

• animal consumption: pets, zoo animals, farm animals.

3.6.2.2 Intended use ⁹

Clause 6 (3)(b) of the RMP spec requires you to document whether your product requires further processing or is ready to consume and may include further details where known, e.g. further processing may be described as canning, pasteurisation, drying etc.

3.6.3 Limits

Regulatory and operator-defined limits define the suitability for processing of animal material, or fitness for intended purpose of animal product. The effectiveness of the RMP can be validated against these criteria.

Limits that are essential for food safety should be considered at CCP determination and may result in a CCP or may be adequately covered by GOP (see section 3.8).

3.6.3.1 Regulatory limit

A regulatory limit is a measurable regulatory requirement that is critical to the fitness for intended purpose of animal material or animal product; e.g. pasteurisation parameters for milk or cooking times and temperatures for a ham.

Regulatory limits must be documented in the RMP and must be met.

You must consider all relevant legislation including

• Animal Products Specifications Notices e.g. Animal Products (Specifications for Products Intended for Human Consumption) Notice clause 121 for raw harvested bivalve molluscan shellfish;

• Australian New Zealand Food Standards e.g. Standard 1.6.1 Microbiological Limits for Food and Standard 1.3.1 Food Additives.

Regulatory limits for dairy products can be found in the relevant Approved Criteria.
Examples of regulatory limits are given in Appendix E.

3.6.3.2 Operator-defined lmits

Operator-defined limits are measurable limits that are established by you to manage the fitness for intended purpose of your products. These are limits that are essential for food safety but have not been set in legislation for the specific product or risk factor of concern.

Examples of possible operator-defined limits are:

• intrinsic parameters of the final product (e.g. pH, moisture content or water activity)

• microbiological criteria defining the maximum acceptable level of a hazard in a product for food safety. An example is the absence of C. botulinum in shelf stable low acid canned product

• maximum levels of physical hazards (e.g. foreign material such as rubber, fibres, metal, bone); and

• maximum levels of chemical hazards.

You must demonstrate that the operator-defined limits are appropriate to your product, considering its intended use, intended consumer and expected handling after leaving the RMP¹⁰. Evidence to justify the selection and level of operator-defined limits may include:

• approved COPs, Templates & Models (see section 2.3.1)

• peer-reviewed scientific information (see section 2.8)

• predictive models (mathematical modelling) (see section 2.9)

• scientific information from a person or organisation known to be competent

• international standards or journal articles

• previous validation studies or historical knowledge on performance of the control measure. You must ensure that the conditions (e.g. raw materials, relevant hazards, combination of control measures, intended use or distribution) in your particular operation do not differ from the conditions under which the control measure was previously validated.

If the parameter is taken directly from one of the above sources, then referring to that source should be adequate justification.

If the parameter is not taken directly from one of the above sources, then you will need to prove that the selected parameter is valid. You may use data from your own experiments or trials. Examples of this approach are laboratory trials and pilot tests of the process.

Examples of operator-defined limits are given in Appendix E.

3.6.4 Actions to be Taken when Limits are not Met

You must document the actions that will be taken (restoration of control, product disposition and preventative action) if any limits are not met e.g. Listeria monocytogenes is detected in cooked cured meat or metal is detected, including any response specified by NZFSA e.g. DPC1: Approved Criteria for General Dairy Processing, 17 Disposal of Non-conforming Dairy Material or Dairy Product.

3.6.5 Other Product Details

You may also include other animal material and animal product details in the product description where appropriate, e.g. requirements for post-mortem examination, packaging, storage, shelf-life and/or labelling.

3.6.6 Examples of Animal Material and Animal Product Descriptions

Table 3E: Examples of Product Description

Requirement	Example 1	Example 2	Example 3
Product.	Raw sheep carcasses, cuts, trimmings.	A grade shell eggs.	Cheese.
Intended consumer.	General public.	General public.	General public.
Intended use.	Further processing into manufactured products, retail products, food service items To be cooked before consumption.	May be cooked or consumed raw.	Ready to eat.
Regulatory limits11.	None.	None.	Maximum limit (Approved Criteria DPC1). Salmonella spp. ND/25g. L. monocytogenes ND/25g. Coagulase positive Staphylococci (S. aureus). 1000cfu/g. B. cereus 1000cfu/g. E. coli 100cfu/g.
			72°C for 15 sec.
Operator-defined limits.	None.	None.	None.
Other product details.	Packaging and labelling as per company specification (refer to document xx)12. Frozen to -12oC.	HC Specification 107. FSC standard 2.2.2. Have been candled and packed. Shelf life. To be stored at or below 15oC.	FSC Standard 2.5.4.

3.7 Process Description

The simplest way to describe your process is to use process flow diagrams showing all inputs, activities or steps, and outputs. These diagrams provide the foundation for hazard and other risk factor identification and hazard analysis.

Inputs include:

• animal materials or animal products, e.g. raw milk, live sheep, red meat, fish, eggs, honey

• other ingredients, e.g. starch, water, salt, spices

• additives / processing aids, e.g. preservatives, antioxidants, colourings, gaseous packing agent; and

• packaging.

You should show the main activities or steps in the process including any rework or recycling, and multiple processing streams. Key process parameters should also be included in the process flow, e.g. processing times and temperatures. This is especially important if you will be submitting an RMP outline for registration. This will assist NZFSA to assess your RMP and minimise the amount of further information that may be requested to clarify the effectiveness of your RMP.

Outputs include all animal materials or animal products leaving your RMP and should be shown irrespective of their intended use, e.g. human consumption, animal consumption, industrial/technical use and waste.

3.8 Good Operating Practice/Supporting Systems ¹³

3.8.1 Background

Good operating practice (GOP) includes the practices and procedures designed to ensure consistent production of products that are fit for their intended purpose.

GOP includes several interacting components, such as good hygienic practices (GHP), effective process control and other quality assurance systems.

GOP is typically documented in supporting systems. ¹⁴

3.8.2 GOP Covered in Supporting Systems

You should document GOP that are necessary for your operation. A good place to start is to ensure you document all procedures required under the Animal Products (Specifications for Products Intended for Human Consumption¹⁵) Notice or the Animal Products (Dairy Processing Specifications) and related Approved Criteria. This is likely to include but is not limited to systems covering:

a. design, construction and essential services

b. premises hygiene and maintenance

c. health and hygiene of personnel

d. competency of personnel

e. calibration

f. packaging

g. labelling

h. inventory control and traceability

i. chemicals

j. pest control

k. supply of animal material

l. incoming materials

m. control of operations, hygienic techniques and process control

n. product specific procedures

o. storage

p. transportation; and

q. recall.

3.8.3 Contents of Supporting Systems

You must ensure that supporting systems meet all relevant regulatory requirements. In many cases NZFSA has developed sector specific COPs. It is recommended that you consult these documents when developing these systems.

NZFSA recommends that supporting systems contain the following:

1. Purpose and scope

2. Authorities and responsibilities

3. Materials and equipment (where appropriate)

4. Procedures covering:

a. control measures – see section 3.8.3.1

b. monitoring – see section 3.8.3.2

c. corrective action – see section 3.8.3.3; and

d. operator verification – see section 3.8.3.4.

5. Recording / reporting; and

6. References to other relevant documents.

Sufficient detail must be given in the supporting systems to ensure that managers and staff know what to do, to assist in staff training and to ensure clear understanding by other people such as the external verifiers and recognised evaluators.

3.8.3.1 Procedures for control of operations¹⁶

You must document:

• the procedures for each process step, including rework

• instructions necessary to make the product correctly (what, when, where, how and by whom); and

• any parameters and the limits for those parameters at each process step (e.g. pH during curing, time and temperature requirements for cooking).

3.8.3.2 Monitoring procedures

You must document procedures for monitoring control measures and applicable limits. Monitoring procedures should include the:

• identify of the person or position responsible

• method of monitoring

• acceptance criteria or limit

• frequency and sampling regime if applicable; and

• records to be kept.

The frequency of monitoring must be appropriate to ensure consistent process control.

3.8.3.3 Corrective action procedures

You must document corrective action procedures which are implemented when a non-compliance to documented procedures and/or failure to achieve a limit is identified. Your corrective action procedures should include:

• the identity of the person or position responsible

• procedures for restoration of control

• procedures for control and disposition of non-complying product, including checking of product back to the last good result

• any action necessary to prevent reoccurrence

• escalating response if preventative action fails; and

• records of all of the above.

3.8.3.4 Operator verification procedures (also see 3.16)

You must document operator verification procedures which ensure that GOP has been implemented effectively, monitoring is occurring and that appropriate corrective action is taken when limits are not met. Operator verification includes activities such as internal audits, achievement of regulatory and operator defined limits e.g. product testing, effectiveness of hygiene and sanitation programmes e.g. environmental testing, compliance to specifications (e.g. ingredient testing) and reviews of the RMP. These procedures should include:

• the identity of the person or position responsible

• procedures for when ongoing operator verification is to be carried out

• procedures for how it will be done

• follow up action to be taken if non-compliance is detected; and

• how the above activities are recorded.

3.9 Application of HACCP (Identification, Analysis and Control of Hazards to Human or Animal Health)

(Section 17 (3) of the Animal Products Act)

You must apply HACCP principles to your process. This ensures a systematic approach to the identification, analysis and control of hazards. The principles of HACCP, as defined by Codex are:

1. Conduct a hazard analysis

2. Determine the critical control points (CCPs)

3. Establish critical limits

4. Establish a system to monitor the control of the CCP

5. Establish the corrective action when monitoring indicates that a particular CCP is not under control

6. Establish verification procedures

7. Establish documentation concerning all procedures and records relevant to the HACCP principles and their application

The HACCP approach is based on the expectation that GOP is effectively implemented prior to the application of HACCP principles.

You are only required to apply the HACCP principles to the actual process, including all inputs to the process.

The application of HACCP principles must be documented. The person or people assigned to this task must have the appropriate knowledge and skills regarding HACCP and the particular processes.

You must review your application of HACCP whenever changes in the product, process and/or premises are made.

3.9.1 Types and Sources of Hazards

A hazard is described as biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

• biological hazards include microorganisms (e.g. Salmonella spp., Listeria monocytogenes), parasites (e.g. Taenia saginata) and biotoxins. ¹⁷

• chemical hazards include heavy metals, pesticides and veterinary medicines. Some food additives may also be hazardous if present in excessive or toxic amounts (e.g. nitrite).

• physical hazards are objects in food that may cause illness or injury. Some examples are glass, metal fragments, stones, bone slivers and shotgun pellets.

Hazards may occur as a result of:

• an input

• the process itself; or

• contamination from “other sources”, such as personnel, water, air, pests, wastes or processing equipment.

3.9.2 Hazard Identification and Analysis

3.9.2.1 Hazard identification

You should only consider hazards that are “reasonably likely to occur” in your hazard identification. Reasonably likely to occur means that:

• the particular hazard is known to occur in the particular food based on scientific reports, industry or company results, COPs, and information from NZFSA; and

• the hazard is known to occur in New Zealand (care should be taken when considering overseas information).

You may use generic HACCP plans or generic RMPs as a basis for your hazard identification but you must then consider whether there are additional hazards that are reasonably likely to occur for your specific product, process and operation. This is particularly important for unusual or novel products such as placentas and glands.

Hazards may be identified by group based on their common characteristics, source and/or control. Examples include: enteric pathogens in beef trimmings, marine biotoxins in shell fish, chemical residues in fresh meat, enteric pathogens in raw milk.

However, certain hazards that require specific controls must be explicitly identified. Examples of these hazard / product combinations include: Campylobacter in raw chicken, Staphylococcus aureus in cooked ham, Listeria monocytogenes in ready-to-eat smoked fish, tutin toxin in honey, the pesticide 1080 in possums, Salmonella in raw milk, and metal fragments in meat and bone meal.

You should avoid vague descriptions of hazards. For example, “foreign objects in a manufactured meat product” or “foreign matter in a dairy product” should not be used as it does not clearly identify the hazard (e.g. metal, bone, plastic) which may require different control measures.

You must be careful not to mix up the source or cause of the hazard (e.g. faecal contamination) and the hazard itself (e.g. enteric pathogens).

3.9.2.2 Identification of hazards from inputs

You should identify the hazards that are reasonably likely to occur for each input.

Supplier quality assurance programmes are typically the most practical way to manage the hazards in incoming raw materials and ingredients. Supplier quality assurance programmes may include; agreed material specifications, supplier declarations for live animals, certificates of analysis for ingredients, supplier audits, and periodic testing of incoming materials. Supplier specifications and procedures should be documented in the RMP.

Hazard identification may be presented in a table, as shown in Table 3F.

Table 3F: Hazard Identification for Inputs

Inputs	Description/ specification	Biological hazard (B)	Chemical hazard (C)	Physical hazard (P)
Beef cuts and trimmings.	Sourced from company with a registered RMP. Chilled or frozen as per company specification. Boneless cuts.	Enteric pathogens, e.g. Campylobacter jejuni, Clostridium spp., Salmonella spp., E. coli spp.	Chemical residues.	Bone Metal.
Raw milk.	Sourced from farm dairy with registered RMP. Chilled storage.	Non-spore forming pathogens e.g. Salmonella, Listeria, E. coli, Mycobacterium bovis (TB). Spore forming pathogens e.g. Clostridium perfringens, Clostridium botulinum.	Chemical residues from cow, e.g. antibiotics, pesticides, heavy metals.	None.
Walnuts.	Supplier approved programme. Supplier specifications.	None18.	None.	Walnut shell.
Salt.	Food grade.	None.	None.	None.
Spices.	Decontaminated.	Spore forming organisms, e.g. Bacillus cereus, Clostridium spp.	Chemical residues, e.g. herbicides, fumigant.	Stones.
Egg pulp.	Pasteurised. Frozen. Meets Food Stds Code, Std 2.2.2	None.	None.	Egg shell.
Bivalve molluscan shellfish.	Raw shucked (prior to testing as per HC Specification Part 13). Sourced from registered RMP.	E. coli spp., Salmonella spp.	Marine biotoxins.	Shell.
Plastic bag (packaging).	Suitable as food contact material (HC Specification Part 6). Protected from contamination.	None.	None.	None.

3.9.2.3 Identification of hazards at each process step

You should identify the hazards that are introduced into the product as a consequence of applying the process step itself. The potential impact of the process step on any existing hazard should also be considered during hazard analysis. Hazard analysis should be done for each step.

3.9.2.4 Identification of control measures

You should identify any control measures for each identified hazard at each process step.

A control measure is any action or activity that is applied to:

• control the initial level of hazard (e.g. testing and rejection of unacceptable ingredients, good animal production practices);

• prevent an unacceptable increase of the hazard (e.g. chilling, reduction of water activity, use of preservatives, acidification); and

• reduce or eliminate the hazard (e.g. pasteurisation, commercial sterilisation, use of antimicrobial agents, trimming, washing).

3.9.2.5 Uncontrolled hazards

If control measures do not exist at any of the steps in the process or are inadequate to control a particular hazard to the required level, you should:

• consider redesigning the process or adding other control measures to control the hazard; or

• leave the hazard uncontrolled when it is appropriate to do so considering the intended use of the product and clearly indicate this in the documented hazard analysis. There must be sufficient documentation to support this decision, and the uncontrolled hazard must be clearly indicated in the hazard analysis. You should also consider whether you need to inform a further processor, retailer or consumer about the uncontrolled hazard so that food safety can be assured prior to consumption.

3.9.3 Critical Control Point (CCP) Determination

You should determine whether there are any CCPs in your process.

A CCP is a step in the process at which control of one or more hazards is applied and is essential for food safety.

To decide whether or not a step is a CCP, you need to determine if the control at that step is essential (by itself or in combination with other steps) to achieve any relevant regulatory limit or operator-defined limit relating to specific hazard(s).

When determining if control at the particular step is essential, you should consider:

• the degree of hazard control that is achieved at the step

• likelihood of failure; and

• consequence of control failure considering the intended use and consumer (i.e. risk to health).

Generally, essential steps are those that are specifically designed to eliminate the hazard or reduce it to an acceptable level.

You should use a systematic approach to hazard analysis and CCP determination for each process covered by the RMP. This must be documented including justification for the hazards and CCPs identified. Justification may be based on information such as historical records, technical publications, COPs or information provided by NZFSA.

Tools that may be used include decision trees and tables that provide a series of questions to guide the user through the decision-making process. The decision tree and/or table currently used by NZFSA has been adapted from the Codex decision tree for use by the animal products industry (see Figure 3G and Table 3H).

When you identify a CCP, the remaining HACCP principles must be applied (see 3.9.4 -3.9.8). When there are no CCPs identified, verification, documentation and record-keeping still need to be applied (see sections 3.9.7 and 3.9.8).

3.9.3.1 Other CCPs that may be identified

You may be required to identify other CCPs in your process to satisfy an overseas market access or customer requirement. No further justification for the identification of these CCPs is necessary, however, they must be clearly identified as market access CCPs, to ensure their appropriate external verification. The Recognised Agency will verify the effectiveness of any market access CCP against the relevant OMAR.

Figure 3G: Decision Tree for Hazard Analysis and CCP Determination

Table 3H: Hazard Analysis and CCP Determination Template

Process step.	Inputs.	Hazard reasonably likely to occur on or in the product at this step.	Justification.	Q1. Is there a control measure(s) for the hazard at this step? If yes, identify the control measure and then answer Q2. If no, consider hazard at next step.	Q2. Is the control measure at this step essential to food safety as defined by a regulatory limit or operator-defined limit? If yes, this step is a CCP. If no, this step is not a CCP.	CCP No.

To clarify the use of Table 3H, each column is discussed below. You should go through the series of questions for each step in the process. The hazard analysis must show any hazard that is uncontrolled at the end of the process. Examples of the use of this table can be found in a number of NZFSA Codes of Practice. See the Meat Code of Practice for one example.

Column 1 - Process step

Each process step should be written in column 1 in the order shown in the process flow diagram.

Column 2 – Inputs

All inputs at the particular step should be indicated in column 2. This should align with the process flow diagram.

Column 3 – Hazard identification

The hazards reasonably likely to occur at each process step should be identified considering:

• hazards introduced by inputs at that step

• hazards introduced or transferred as a consequence of applying the process step itself (e.g. metal from mincers)

• hazards carried over in the product from the previous step; and

• adverse impact of process step on existing hazards (e.g. growth of microorganisms).

Column 4 – Justification

A brief justification for each identified hazard should be provided. This should include the identification of the source or cause of the hazard. Justification may be based on company experience and records, scientific literature, surveys, industry reports, COPs, generic HACCP plans and other NZFSA guidance documents.

Column 5 – Question 1: Identification of control measures

You should identify the control measure for each hazard. The procedures for all control measures must be documented in the RMP (e.g. in supporting systems). The document number or title of the particular supporting system should be given in this table to facilitate verification and RMP review.

Hazards that are not completely eliminated at a step should be considered at the next step to ensure that the impact of succeeding steps is considered. In particular, bacterial hazards should be carried over to succeeding steps since there is potential for their growth.

Hazards unlikely to be affected by succeeding process steps (i.e. will not grow or increase), such as chemical residues and parasites, do not need to be carried over to each step in the hazard analysis table to reduce repetition. However, the hazard must be reintroduced to the table at the step that it is controlled, or it must be shown at the last process step, if it is uncontrolled.

Column 6 - CCP determination

Decide whether or not a step is a CCP by determining if the control at that step is essential, by itself or in combination with other steps, to achieve any regulatory limit or operator-defined limits for the specific hazard(s). If there is no regulatory limit or operator-defined limit, there is no CCP.

3.9.4 Establishing Critical Limits

You must define and justify critical limit(s) for each CCP. A critical limit is a criterion which separates acceptability from unacceptability at a CCP.

Critical limits must be measurable and linked to the achievement of a regulatory limit or operator-defined limit related to food safety. They should be parameters that can be monitored on an on-going basis to ensure consistent effectiveness of the process step to achieve the specified level of control.

You must document the:

• parameters to be checked

• limit for each parameter; and

• justification for each limit.

3.9.5 Establish CCP Monitoring

You must document monitoring procedures for each critical limit. These should include the:

• identity of the person or position responsible for monitoring

• monitoring method

• monitoring frequency and sampling regime; and

• records to be kept.

Monitoring could be continuous (e.g. using an automatic measuring and recording device), or based on an established frequency or statistical sampling plan. The frequency must be adequate to ensure consistent control. Other factors to consider when establishing the frequency include: the nature of the product, the likelihood of failing the limits, the cost of monitoring, the consequence of failure (including risk to human health), and expected corrective actions (especially with respect to product disposition).

3.9.6 Establish Corrective Action

You must document corrective action procedures and ensure they are implemented when a critical limit is not met. Corrective action procedures should include:

• the identity of the person or position responsible for taking corrective action

• procedures for restoration of control

• procedures for control and disposition of non-complying product, including checking of product back to the last good result, where possible

• action to prevent a reoccurrence

• escalating response if preventative action fails; and

• records to be kept.

3.9.7 Establish Verification Procedures

You must document verification procedures to ensure that the CCP is implemented effectively, monitoring is occurring as written and that appropriate corrective action is taken when critical limits are not met. These procedures should include:

• the identity of the person or position responsible for ongoing operator verification

• procedures for operator verification activities to be undertaken

• frequency of operator verification activities

• follow up action to be taken if non-compliance occurs; and

• records to be kept.

These verification procedures may form part of operator verification (see section 3.16).

3.9.8 Establish HACCP Documentation and Records

You must document all matters relating to the application of HACCP within your RMP.

Suitable records must be kept to be able to demonstrate that the HACCP part of the RMP has been implemented effectively, e.g. CCP monitoring records, CCP corrective action records and HACCP verification records.

3.9.9 Confirming the Application of HACCP

You should check the application of HACCP after completing the hazard analysis and CCP determination. The following should be considered:

• are the operator-defined limits appropriate and achievable?

• are the identified CCPs essential to comply with the regulatory limit(s) or operator-defined limits for particular hazard(s)?

• are the critical limits appropriate and achievable?

• can the critical limits be monitored effectively?

• are all the identified hazards adequately controlled by GOP and/or a CCP(s)? If not, do you need to modify the process or add other control measures?

• are there any uncontrolled hazards? If so, are you required by legislation to control it/them to a specified level? Do you need to consider redesigning the process/product? Do you need to inform a further processor, retailer or consumer about the uncontrolled hazard so that food safety can be assured prior to consumption (e.g. by providing feedback to suppliers, notifying further processing, or cooking/handling instructions).

3.10 Identification and Control of Risks to Wholesomeness

(Section 4 of the Animal Products Act)

Wholesomeness means that the product does not contain or have attached to it, enclosed with it, or in contact with it; anything that is offensive, or whose presence would be unexpected or unusual in product of that description.

In other words if a consumer would think “Yuck” then it is likely that this is a wholesomeness risk factor. This is greatly dependent on the:

• intended use

• intended consumer

• nature of the product; and

• packaging / identification of the product.

Application of HACCP principles is not required for risks to wholesomeness but NZFSA recommends that you systematically assess each input and step in the process to identify and control any wholesomeness risk factors.

It is unlikely that any risks to wholesomeness will be identified for animal materials or products intended for animal consumption.

3.10.1 Identification of Risks to Wholesomeness

You must identify any risks to wholesomeness that are reasonably likely to occur within your process for each animal material or animal product or group of materials or products. This can be based on:

• guidance given in industry COPs

• your knowledge/experience of your product and process (including a review of internal records and reports); and

• any customer / consumer complaints.

Opinions about what is offensive, unexpected or unusual will vary. Common sense should be used to determine any problems that would be offensive, unexpected or unusual. See Table 3I for examples of likely risks to wholesomeness.

Table 3I: Examples of Risks to Wholesomeness and their Controls

Product	Wholesomeness Risk Factor	Examples of Control Measures	Supporting System (put actual doc no. and/or title)
Whole chickens.	Feathers.	Correct set up of plucker. Inspection of birds.	Doc. xx
Hamburger pattie.	Bones.	Supplier assurance programme. Bone eliminator.	Doc. xx
Milk (farm dairy operator).	Foreign or Objectionable Matter (insects, faeces, dirt or dust).	Ensure teats clean. Filter milk. Bulk milk tank secure from environmental contamination, lidded vats closed at all times except from emptying milk until cleaning complete.	Doc. xx
Shell eggs.	Roundworms.	Worming programme for free-range hens.	Doc. xx
Mussel meat.	Pea crabs.	Inspection and removal.	Doc. xx
Honey.	Fermentation.	Control of moisture content control. Heating.	Doc. xx
Canned corned beef.	Plastic.	Inspection of raw meat blocks, and removal. Use of coloured liners.	Doc. xx
Meat.	Spoilage.	Temperature control. Hygienic practices.	Doc. xx

3.10.2 Controls for Risks to Wholesomeness

Where you have identified a risk to wholesomeness, you must document:

• the control measures (see Table 3I for examples); and

• all other matters required by clause 11(2) of the RMP spec as listed above.

The control measures may be documented within process control procedures, supporting systems, or a specific wholesomeness supporting system. If the control measures are documented in different parts of the RMP, NZFSA recommends that you explain this clearly and provide references to the relevant controls for each identified risk factor. An example of how this can be done is shown in Table 3I.

You are not required to set operator-defined limits for wholesomeness risk factors. However, you may wish to do so. Where an operator-defined limit has been documented you must document actions to be taken if those limits are not met.

3.11 Identification and Control of Risks from False or Misleading Labelling

All animal products must meet legislative requirements related to labelling including:

• the Animal Product Regulations 2000, regulations 8 and 19

• Part 7 of the current Animal Products (Specifications for Products For Human Consumption) Notice

• Parts 1.1A and 1.2 of the Australia New Zealand Food Standards Code

• Part 1 of the Food (Safety) Regulations 2002; and where applicable

• the Animal Products (Specifications for Products Intended for Animal Consumption) Notice; and

• the Agricultural Compounds and Veterinary Medicines Act 1997.

When identifying risk factors, you should consider the type of animal material and/or product, its intended use and the requirements of:

• systems to authenticate claims, e.g. species, composition, active ingredients, organics, free range, GM free, claims of effectiveness; and

• specific consumer groups, e.g. religious groups, people with allergies.

Application of HACCP principles is not required for risks from false or misleading labelling.

If products are intended for export, you should ensure the requirements of the relevant market are met.

3.11.1 Identification of Risks from False or Misleading Labelling

You should identify risk factors associated with false or misleading labelling that are reasonably likely to occur for each animal material or animal product or group of materials or products. This can be based on:

• guidance in industry COPs

• knowledge / experience of your product and process (including from review of internal records and reports); and

• customer complaints.

For simple products and processes, there may be little opportunity for these risk factors to occur. A common sense approach should identify those risk factors that are reasonably likely to occur for the operation. See Table 3J for examples of likely risks to false or misleading labelling.

Table 3J: Examples of Risks from False or Misleading Labelling and Their Controls

Labelling Risk Factor	Likely Cause	Control Measures	Supporting system (put actual doc no. and/or title)
Incorrect design (label content/format	Lack of research into label content Using inaccurate or incomplete information	Conduct adequate research Checks on label design Sign-off before release to processing	Doc. xx
Process deficiencies resulting in the product not matching its label	Errors in processing, e.g. wrong product flow, inadequate separation Wrong formulation Cross contamination from equipment with unwanted ingredients, e.g. peanuts (allergens) Inputting wrong information into labeller, e.g. species Wrong packaging materials Changes in raw materials or suppliers (i.e. inadequate supplier quality assurance procedures)	Training and supervision Processing procedures Formulation control procedures Clean down Order of processing Compliance to raw material specifications Material tracking Inventory control Label checks	Doc. xx

3.11.2 Control of Risks from False or Misleading Labelling

Where you have identified a risk to false or misleading labelling you must establish control measure(s) for them. You should document procedures to control each risk factor including all matters required by cause 11(2) of the RMP spec.

The control measures may be documented within process control procedures, supporting systems, or a specific labelling supporting system. If the control measures are documented in different parts of the RMP, NZFSA recommends that this is explained clearly with references to the relevant controls for each identified risk factor. An example of how this can be done is shown in Table 3J.

You are not required to set operator-defined limits for false or misleading labelling risk factors. However, you may wish to do so. Where an operator-defined limit has been documented you must document actions to be taken if those limits are not met.

3.12 Identification and Competencies of Responsible Persons

3.12.1 Identification of Responsible Persons

You must identify responsible persons at appropriate places within the RMP in any format that suits the operation. These persons include:

• day-to-day manager of the RMP (see section 3.4.1)

• authoriser(s) of the RMP (see section 3.19.2)

• persons responsible for key tasks (see section 3.12.1.1); and

• persons requiring specific mandatory competencies (see section 3.12.1.2).

For effective implementation of the RMP, the responsible persons and back-up staff must have an appropriate level of competency in the application of HACCP principles and knowledge of the RMP. You may do this by on-the-job training, have the responsible persons attend training courses and/or may have them assessed against relevant competency standards, e.g. those available from the NZ Qualifications Authority. The available NZQA standards include:

a. 12315: Supervise a seafood processing operation under a HACCP System

b. 12316: Coordinate the development and verification of a HACCP plan for a seafood processing operation

c. 12624: Monitor a meat processing operation under a HACCP System

d. 12625: Supervise a meat processing operation under a HACCP System

e. 12626: Coordinate the development and verification of a HACCP plan for a meat processing operation

f. 19514: Explain the application of HACCP principles

g. 19515: Explain development and implementation of RMPs under the APA

h. 16667: Coordinate the development and verification of a HACCP plan in the dairy industry

i. 18407: Explain the workplace application of HACCP in the dairy industry

3.12.1.1 Persons responsible for key tasks

You must document, by name, position or designation, the person(s) responsible for carrying out the following key tasks (including any within supporting systems):

• control activities (including those at CCPs), e.g. calibration tasks, purchasing approved chemicals, setting critical parameters on equipment

• monitoring activities, e.g. pre-operative checks, temperature checks

• corrective actions; e.g. restore control, product disposition, prevent recurrence

• operator verification activities; e.g. record checks, internal audits, RMP review; and

• recall.

The task assignments will depend on the complexity of the operation. In simple operations, it may be that one person is responsible for all of the activities. In a more complex operation, several people are likely to be responsible for different parts of the programme. You may designate these responsibilities to different people at different times, e.g. by roster. If this is the case, then the method of designation must be documented, including who is responsible for ensuring that this happens. You should also document how back-up personnel are assigned to cover for holidays and absences.

3.12.1.2 Persons required to have specific mandatory competencies

There are some mandatory competency requirements for persons who are responsible for certain specific operations / activities, for example those who are responsible for supervising canning operations. These mandatory competencies are listed in the:

• Animal Products (Specifications for Products Intended for Human Consumption) Notice, Part 4

• Animal Products (Specifications for Products Intended for Animal Consumption) Notice, clause 23; and

• Animal Products (Dairy) Approved Criteria for the Manufacturing of Dairy Material and Products (DPC3), section 22, section 23 and Appendix 1.

3.12.2 Competencies of Responsible Persons

Once you have identified the responsible persons, you must document their required competencies for carrying out their tasks effectively. An example of how you could do this is shown in Table 3K.

You must keep training records for each staff member with responsibilities under the RMP.

Table 3K: Competencies of Responsible Persons

Person	Authorities and responsibilities	Training, knowledge or experience
Operator of RMP	Legal representative for the RMP (see section 3.2)	Has a good understanding of relevant regulatory requirements under the APA including operator duties and the Food Standards Code (for human consumption)
Day-to-day manager(s) of the RMP (including any deputies)	Responsible for the day-to-day management of the RMP (see section 3.4.1)	Has: - a thorough understanding of RMP requirements, e.g. through experience in developing an RMP or by meeting an appropriate RMP NZQA (New Zealand Qualifications Authority) Unit Standard - appropriate technical competencies, e.g. relevant scientific, food technology or food safety qualifications which may be demonstrated by meeting an appropriate HACCP coordinator NZQA Unit Standard - a complete knowledge of the operations, processes and systems that are included in the RMP, e.g. through on the job training
RMP authoriser(s)	Signs off the RMP documents and any amendments to the documents (see section 3.19)	Same as for the day-to-day manager of the RMP but only in relation to the part(s) of the RMP they are responsible for authorising
Person(s) undertaking document checks and validation RMP	Confirms that the RMP is appropriate, complete, complies with legal requirements, and is implemented effectively	Same as for the day-to-day manager of the RMP but only in relation to the part(s) of the RMP they are responsible for confirming
Persons responsible for control activities	See sections 3.8, 3.9, 3.10 and 3.11	Has thorough knowledge of: - the relevant operations, processes and systems in the RMP, - the control measures for each activity they are responsible for and how to recognise loss of control and - the appropriate response when there is a loss of control
Persons responsible for monitoring activities	See sections 3.8 and 3.9	Same as for persons responsible for control activities. They may also have an appropriate supervisor NZQA Unit Standard
Persons responsible for corrective action activities	See sections 3.8, 3.9 and 3.13	Same as for persons responsible for monitoring activities. They also must have the ability to identify product non-conformances. A supervisor and/or HACCP coordinator NZQA Unit Standard would be appropriate for this role
Operator verification activities	See sections 3.8, 3.9 and 3.16	Same as for day-to-day manager of the RMP. They also must have the ability to interpret records and results. This may be demonstrated by appropriate internal audit training
Recall Manager	See section 3.14	Has a thorough understanding of Recall policies and procedures. They may also have an appropriate HACCP coordinator NZQA Unit Standard
Specific mandatory competencies	See section 3.12.1.2	The required competencies are mandated in legislation

3.13 Corrective Action for Unforeseen Circumstances

In addition to the corrective actions for non-compliances to documented procedures and parameters, you must also document in your RMP, corrective action procedures for unforeseen circumstances, for example if there is a fire in part of the premises or flooding occurs. This should include documenting who is responsible for nominating a suitably skilled person ¹⁹ to manage these corrective actions. The suitably skilled person is responsible for:

a. identification, retention and assessment of non-complying product (including as appropriate a review of relevant processing records, analyses undertaken, inspection of animal material or animal product, expert advice, literature review etc)

b. product disposition²⁰ as appropriate to the nature of the problem and the intended use of the product (e.g. rework, reject, release under restricted conditions, regrade for alternative use where permitted under the RMP); and

c. reporting to the recognised verifier including:

i. a description of the problem and the affected animal material or animal product

ii. a summary of the assessment made

iii. the decision on the disposition of the animal material or animal product; and

iv. any actions taken to prevent recurrence of the non-compliance.

3.14 Recall Procedures

(Section 17 (2) (c) of the Animal Products Act)

There may be times when non-complying animal material or animal product is produced. If the non-compliance is detected before any of the affected products are released for distribution or sale, you should take appropriate corrective actions to fix the problem and determine the proper disposition of affected products. However, if some or all of the products are in the distribution chain or with the consumer, then you may need to initiate a product recall to recover the products as quickly as possible. Your decision to recall product should be based on whether or not the product is fit for its intended purpose, considering both safety and suitability issues. ²¹

You must document recall procedures where, due to the nature of the product, it is possible for your product to be recalled. The exception is where your product is intended to be consumed immediately. Your recall procedure should cover voluntary recalls, and recalls required by the Director-General, under section 85 of the APA 1999.

You should include the following when establishing your recall procedures:

a. a system to identify and trace all inputs, work-in-progress and final products

b. responsibilities and authorities for recalls, including recall management and notification to the Director-General and the recognised RMP verifying agency

c. media statements, including a draft recall notice

d. criteria for deciding whether a recall is necessary (i.e. impacts on fitness for intended purpose)

e. communication and documentation, including notification to the Director-General and the recognised verifying agency

f. product recovery and disposition

g. corrective and preventive action; and

h. review of recall effectiveness.

Guidance documents which may assist you to develop appropriate recall procedures are available on the NZFSA website: Food Recalls for Manufacturers.
http://www.nzfsa.govt.nz/processed-food-retail-sale/recalls/index.htm

3.15 Validation

See section 4 for more detail on validation.

You must confirm that the RMP is valid. Where there is insufficient evidence to demonstrate the effectiveness of the RMP, you may need to develop a protocol. You must adhere to the timeframes for completion of the protocol unless otherwise agreed with the recognised evaluator or NZFSA.

3.16 Operator Verification

Operator verification is the application of methods, procedures, tests and other checks to confirm that the RMP:

• is still applicable to the operation

• remains in compliance with all legislative requirements

• continues to be implemented as written; and

• is producing material suitable for processing or product fit for its intended purpose.

Ongoing operator verification activities may include:

• review of monitoring records

• product tests

• review of non-conformance and corrective action records

• calibration checks

• internal audits; and

• periodic review of the complete RMP.

You should document the verification activities including:

• when, how, and where they will be carried out

• the identity of the person(s) or position who will carry them out

• actions to be taken if deficiencies are found; and

• records to be kept to show that verification has been done as planned.

You must define the frequency of verification activities, which may be performance based and vary for different parts of the RMP.

Ideally persons carrying out operator verification activities should be independent of the processes being verified, i.e. they should not check their own work. In small operations this may not always be possible.

3.17 Notification Requirements

You must have documented procedures for how you notify NZFSA or the recognised RMP verifying agency of the requirements in clause 13.

3.18 Provision for Verification Activities and Verifiers Rights

(Sections 17 (4) of the Animal Products Act)

You must make provision in the RMP for verification activities and verifiers rights, as described in the specification above. You can do this by copying the specification directly into the RMP or by referencing clause 17 of the Animal Products (Risk Management Programme Specifications) Notice 2008.

You must also get written confirmation from a recognised RMP verifying agency indicating that they have agreed to provide verification services for your RMP. This is typically a letter which is considered to be part of the RMP and must be submitted with the other documentation required for registration.

You are responsible for contracting the services of a recognised verifier. All recognised verifying agencies are listed on NZFSA web site

http://www.nzfsa.govt.nz/animalproducts/registers-lists/recognised-agencies/index.htm (non-dairy) and

http://www.nzfsa.govt.nz/dairy/registers-lists/dairy-recognised-agencies.htm (dairy)

See section 7.4 for further details about external verification.

3.19 Document Control

3.19.1 General

(Sections 17 (1) (a) and (d) of the Animal Products Act)

You must document all components of the RMP. You should ensure that the format used for the RMP is user friendly for relevant staff, the evaluator and external verifiers.

There is flexibility in how you can document your RMP. You may reference documents such as a Code of Practice, HACCP plan or other documented procedures rather than reproducing them in the RMP. These documents then become part of the RMP. When only parts of a referenced document apply to your RMP, you must show which parts of the document are included in or excluded from the RMP. You can do this by:

• using different formats for parts, e.g. bolding, highlighting, using boxes, colour-coding; or

• describing those parts that are excluded, e.g. all references to animal welfare or overseas market access requirements.²²

All documents relevant to your RMP must be made available to evaluators, verifiers and regulators, as necessary. Made available means that no matter where the documents are stored, they can be mailed, couriered, faxed, emailed or transferred by other means within 2 working days.

3.19.2 Authorisation of Documents

All your RMP documents must be authorised by a person with appropriate authority before the RMP is registered and after any amendments are made. This must be done by a person with appropriate authority as required by the RMP Specifications 2008 clause 19(1)(c).

Authorisation can be done either by signing each page of the RMP or by some other way described in the document control system, e.g.:

• signing a detailed document list or contents page that shows the current dates or versions and number of pages of each document or part-document; or

• appropriate electronic means so long as there are sufficient controls on access to passwords, authorisation codes, electronic signatures.

3.19.3 Making Amendments

Your document control procedures must explain how you make a significant or minor amendment. These should include procedures for:

• identifying the need for an amendment

• documenting the amendment

• deciding if the amendment is significant (as per Section 25 of the APA and as clarified in the RMP Specs 2008 clause 22 and Appendix G of this manual), with appropriate justification and if significant, proceeding with evaluation and registration described later in this manual

• authorising and issuing the amendment and removing obsolete documents; and

• implementing the amendment.

3.19.4 Identification of Amendments

You must document how amendments to the RMP are identified. Examples of ways to indicate amended parts of an RMP are:

• increasing the version number of amended pages or sections

• placing a line in the margin of relevant pages showing where amendments have been made

• highlighting or otherwise changing the format of the amended sections; or

• describing the changes in an amendment page.

3.20 Requirements for Records

(Sections 159 and 160 of the Animal Products Act)

3.20.1 Electronic Records

Where records are kept electronically, you must document the systems to manage access to files and ensure appropriate back-ups are made. You must also ensure that:

• electronic records cannot be altered without authorisation

• any alterations are noted; and

• records are accessible to relevant personnel (e.g. internal auditor, verifier).

3.21 Specific Requirements for Dual Operator Butchers

(Section 71 of Animal Products Act)

A dual operator butcher (DOB) is a retail butcher who:

• is listed by the Director-General as a homekill or recreational catch service provider; and

• processes homekill or recreational catch at the same premises or place as the retail butcher processes or trades in regulated animal product.

DOBs must have a registered RMP before trading regulated animal product (see definition in appendix A) to ensure that any such product is fit for its intended purpose.

In addition to the components required for a normal RMP, a DOB RMP must include:

• the identification and control of the risk factors introduced to the regulated product from homekill or recreational catch that is processed in the same place

• control measures to ensure that homekill and recreational catch products are processed and stored separately from and are not mistaken for regulated animal products and do not enter trade (except for rendering as permitted under APA s69(3)(b)); and

• control measures to ensure that product from the business is not exported.

A DOB must also document specific inventory control measures to comply with the Animal Product (Homekill and Recreational Catch Service Provider Records and Information) Specifications, which gives the minimum requirements for record-keeping. This can be found at the following web site: http://www.nzfsa.govt.nz/animalproducts/legislation/notices/homekill-recreational.htm.

NZFSA has developed an RMP template to assist preparation of DOB RMPs. This template has been approved so RMPs that are fully based on it do not need to be evaluated prior to registration. See http://www.nzfsa.govt.nz/animalproducts/subject/dual-butcher/index.htm for the template and other useful resources.

⁴ Note that for the purposes of the RMP Manual, animal material and animal product includes dairy material and dairy product.

⁵ A fit and proper person must not have any conviction for an offence, in relation to fraud, dishonesty or negligence, whether in New Zealand or overseas, in regard to running a business of the type covered by the APA.

⁶ For the purposes of carcass brands, inspection legends and carton seals, there will be a physical limit of 6 characters.

⁷ This provides links to a list of currently registered RMPs only. Identifiers from RMPs that are no longer registered are also not available for your use. You will need to confirm availability with NZFSA.

⁸ For RMPs that only maintain animal materials or animal products in the condition that they received them from another RMP, e.g. stand-alone stores, it is acceptable to state that this information is covered by the supplier’s RMP(s).

⁹ See previous footnote.

¹⁰ The Microbiological Reference Criteria issued by the Ministry of Health relates to criteria at the end of shelf life. For this reason, it may be inappropriate to use these criteria in the RMP as they may be too high for use at the point of release from an RMP. For guidance on this and other microbiological limits that are commonly used for finished products see http://www.nzfsa.govt.nz/processed-food-retail-sale/fact-sheets/which-micro.htm

¹¹ If limits exist, then operator must also document actions to be taken when limits are not met.

¹² This could be a reference to a company document where the packaging specification is located.

¹³ Good Operating Practice includes Good Manufacturing Practice (GMP) and Good Hygienic Practice (GHP).

¹⁴ These systems may also be referred to as Standard Operating Procedures (SOPs), Sanitation Standard Operating Procedures (SSOPs), GMP procedures and pre-requisite programmes.

¹⁵ Or alternatively, consider the Animal Consumption specifications - depending on the intended consumer for products made.

¹⁶ For procedures relating to other supporting systems e.g. premises hygiene and maintenance, refer to the COP developed by NZFSA for the various sectors.

¹⁷ Biotoxins could instead be listed under chemical hazards. Either approach is acceptable.

¹⁸ “None” means hazards are not reasonably likely to occur because they are not associated with the input or it is controlled through supplier agreements.

¹⁹ The actual person should not be nominated until a problem occurs, as the skills needed will depend on the nature of the problem. This person may be a staff member or may be an external consultant with expertise relevant to the situation. This person should not be the recognised verifier of the RMP as this would create a conflict of interest during verification.

²⁰ Exception reporting and disposition of non-conforming dairy material and dairy product must be undertaken as outlined in DPC1: Animal Products (Dairy) Approved Criteria for General Dairy Processing.

http://www.nzfsa.govt.nz/dairy/publications/approved-criteria/index.htm

²¹ You may decide to withdraw product if it is safe and suitable, but does not meet non-regulatory (commercial) requirements. In this case a formal recall is not required.

²² Inclusion of an export requirement into the RMP, either directly or by reference, means that it must be evaluated against the NZ standard and registered as part of the RMP. Once registered, the company must comply with the RMP. It is recommended that these requirements are not integrated into the RMP.