Guidance for Manufacturers of Feedingstuffs containing ... file · Web viewThese documented procedures and HACCP plan should be reviewed on an annual basis or whenever a significant

Documented Procedures & HACCP Plan

Guidance for Approved Manufacturers of Schedule 5 Products

# Last updated October 2011

Introduction:

The procedures laid down in this document are intended to assist approved Manufacturers of specified feed additives (SFAs*), premixtures and feedingstuffs containing SFAs, and premixtures and feedingstuffs containing veterinary medicinal products (VMPs) – collectively referred to as Schedule 5 products - to comply with the requirements of the Veterinary Medicines Regulations; and in particular to ensure that Schedule 5 products are manufactured, stored and supplied in such a way to minimise the risk of errors, contamination and cross-contamination.

*SFAs include coccidiostats, histomonostats and non-antibiotic growth promoters.

This document should be read in conjunction with Veterinary Medicines Guidance Note 17 - Medicated Feedingstuffs and Specified Feed Additives, which is available on the VMD website www.vmd.defra.gov.uk or by contacting the VMD at:

VMDWoodham LaneNew HawAddlestoneKT15 3LS

Tel: 01932 336911 Fax: 01932 336618e-mail: [email protected]

These documented procedures and HACCP plan should be reviewed on an annual basis or whenever a significant change to the manufacturing and distribution operation or equipment is made. A record of review should be kept (see appendix 1).

Please note that similar requirements exist for non-specified feed additives, which are enforced by Local Authorities.


mailto:[email protected]

http://www.vmd.defra.gov.uk/

Section A. Establishment & Personnel Details

Requirement:

Feed business operators who manufacture Schedule 5 products for placing on the market, or for the exclusive requirements of their own livestock, are required to be approved under the Veterinary Medicines Regulations.

Owner’s Name:

Owner’s Address:

Owner’s Code (Note 1):

Premises’ Address:

Premises’ Code (Note 1):

Premises Category

Date

Note 1. The Owner’s Code and Premises’ Code will be provided by the VMD on approval.


Section B. Feed Details

1 What Schedule 5 products are manufactured? – (Note 2).

2 What is the expected shelf life of the Schedule 5 products, as manufactured? (Note 3)

3 What feed materials are used in the manufacture of Schedule 5 products? (Note 4)

4 How/where are formulation details of the Schedule 5 products manufactured kept? (Note 5).

5 Are the feedingstuffs for (i) feeding solely to own livestock, (ii) for sale, (iii) both?

6 Are the premises certificated by an Assurance Scheme (provide details)?

7 Identify feeds intended for animals whose meat or produce will enter the food chain directly.

Note 2. List the feedingstuffs manufactured and their physical form, e.g. dry sow meal, lactating sow meal, early grower meal, finisher wet feed etc.

Note 3. Specify the expected shelf life of the feedingstuffs manufactured, e.g. dry sow 7 days, finisher fed as mixed etc.

Note 4. List the feed materials used, e.g. barley, hi-pro soya, wheatfeed, C-starch, Company X vitamin/minerals etc.

Note 5. Specify where ration formulations are kept and how changes are recorded. Ensure formulations show the current Schedule 5 products used and manufactured, or likely to be used.


Section C. PERSONNEL

Designated QPFP (Note 6)

Designated QPFC (Note 7)

Other Personnel

HACCP Team Members

Note 6. The Qualified Person for Feedingstuffs - Production (QPFP) is the person who is normally responsible for the manufacturing operation.

Note 7. The Qualified Person for Feedingstuffs - Quality Control (QPFC) is the person with responsibility for all quality matters and should, ideally, be different from the QPFP.

Further guidance on Qualified Persons, is provided in appendix 2 of this document.

Designated Persons:


Designated QPFP’s role & responsibilities; and qualifications and/or experience

Designated QPFC’s role & responsibilities; and qualifications and/or experience

Section D. Facilities & Equipment

Requirement:

All parts of the premises and equipment used for the manufacture, storage and distribution of Schedule 5 products must be kept in a clean and tidy condition and be properly maintained to provide a safe working environment. Measures must be taken to prevent, as far as possible, the entrance and harbouring of pests and spoilage organisms, and an effective control programme must be implemented in these areas.

Windows and other openings must, where necessary, be proofed against pests. Doors must be close-fitting and proofed against pests when closed.

Weighing scales and metering devices used in the manufacture and distribution of Schedule 5 products must be appropriate for the range of weights and volumes to be weighed/measured and must be regularly calibrated. Mixers must be appropriate for the weights and volumes being mixed and must be capable of producing a homogeneous mix. 1. Indicate the cleaning programme for the premises and equipment (Note 8)

2. Indicate the pest control measures taken for the manufacturing and storage areas and equipment (Note 9)

Note 8. Outline the cleaning requirements for the facilities and equipment e.g. (i) Daily – All raw material spillages will be cleaned up and used in production as specified. Feed

spillages will be cleaned up immediately and feed to the designated livestock.(ii) Monthly - the mixing area, equipment and bag storage areas will be cleaned up and unidentified

material suitably disposed of.(iii) Annually - the production equipment, the fabric of the mixing area and all feed and raw material

storage areas will be thoroughly cleaned. Bulk bins and storage areas will be treated for mite & insect infestation, following all Health & Safety guidelines.

Note 9. Outline the pest control policy for the storage and manufacturing premises and areas, including a diagram of the premises showing the location of bait control measures.


Section E. Production

Requirement

The different stages of manufacture, storage and distribution must be documented and written procedures followed to avoid or minimise, as necessary, any cross-contamination and errors. Sufficient and appropriate checks must be carried out in the course of manufacture.

Manufacturers must have adequate measures in place to ensure effective tracing of the products.

Ultimately, manufacturers must have all due regard for the safety of (i) operators; (ii) livestock and wildlife; (iii) consumers; and(iv) the environment.

1. What are the processes used in the manufacture of Schedule 5 products? (Note 10).

Note 10. Outline the processes used in the manufacture of Schedule 5 products, e.g. intake of barley and transfer to grain silo 1; intake of vitamin/mineral supplements to feed store; barley augered to grinder bin and grinder; pneumatic conveying of ground barley to 1 tonne vertical mixer, etc. A flow diagram of these processes will be required for the HACCP plan.


Production Instructions:

(a) Ensure all production equipment is clean before commencing manufacture.

(b) Appropriate personal protective equipment (PPE) for the manufacturing operation must be used e.g. an approved respirator and gloves.

(c) Follow all instructions on the labels of Schedule 5 products to be used, to ensure that undesirable interactions are avoided.

(d) Plan the order of manufacture (schedule) using the following guidelines :-

(i) products containing veterinary medicines/specified feed additives must not be followed by products for a contra-indicated species;

(ii) products containing veterinary medicines/specified feed additives must never immediately be followed by a product for animals whose produce will enter the food chain directly e.g. milking cows, finishing pigs/poultry, layers, unless the medicine/specified feed additive is authorised for those animals and has a zero withdrawal period (NB see section B question 6).

(iii) if necessary flush between mixes using 2 separate batches of product using a ‘flush’ which has been demonstrated to remove residual material of a previous batch. Flushings should be returned to the previous batch, or otherwise appropriately disposed of (and recorded).

(e) For medicated feedingstuffs always follow the instructions given on the MFS prescription.

(f) All production must be carried out with reference to pre-established critical control points (see HACCP Plan).

(g) Never use fishmeal in products for ruminants or through equipment used to manufacture such products.


Section F. Quality Control

Requirement:

Quality control measures must be followed to ensure that Schedule 5 products are manufactured to their specified formulations and that product specification is maintained.

Manufacturers must have a Quality Control (QC) plan which includes, in particular, checks on the critical points in the manufacturing process, sampling procedures and frequencies, methods of analysis and what controls are in place to deal with non-complying products. The quality control plan should be drawn up in conjunction with the QPFC

Appropriate records must be kept to permit the tracing of all Schedule 5 products from intake to delivery of each batch of finished product.

A readily identifiable sample from each batch of manufactured finished product must be retained for an appropriate period, being at least until the shelf life of the product has passed. In the case of livestock owners manufacturing finished feed containing VMPs/SFAs solely for feeding to their own animals, samples of the manufactured should be kept on a regular basis (Note 11).

Quality Control Plan:

1. A homogeneity (mixer efficiency) test must be carried out at least annually, under the direction of the designated QPFC, and the results assessed to determine the efficiency of the mixing equipment and procedures.

2. At least (Note 12) samples of feed must be taken each year and analysed for medicinal/specified feed additive content and the results assessed against the expected level of active ingredient.

1. A number of samples should also be taken for general nutritional and microbiological analysis as part of the quality control plan (Note 13).

2. All weighing and metering equipment must be calibrated or checked as set out below:


3. What checks are carried out to ensure that feed materials including Schedule 5 products are of suitable quality to use in the manufacture of feedingstuffs? (Note 14)

Note 11. (i) (for those manufacturers producing such feeds for sale) A sample of each batch of medicated/specified feed additive feed manufactured must be taken and the samples retained until at least the declared shelf-life;

(ii) (for those manufacturers producing such feeds for feeding solely to their own livestock) A sample of feed must be taken each time a new batch of medicinal/specified feed additive product is started. The 3 most recent samples of each type of feed should be retained.

Note 12. The number of samples to be taken for analysis of medicinal / specified feed additive content should be based on the following formula:-

1% of the t/pa of Schedule 5 products manufactured (minimum 1 sample pa)

Note 13. Suppliers’ certificates of analysis/conformity may be retained.

Note 14. Indicate the checks that will be made on feed materials at purchase/prior to use e.g. visual checks for moulds, foreign objects, insects etc; purchase product X only from an assured supplier; moisture content of 16% or below etc.


SECTION G. STORAGE & TRANSPORT

Requirement:

Schedule 5 products acquired and manufactured, should be stored on appropriate premises and transported in appropriate packaging, containers and vehicles, to ensure good storage conditions and the avoidance of cross-contamination.

Containers and equipment used to store, convey, weigh and transport Schedule 5 products must be kept clean and tidy and a cleaning programme followed and recorded.

1. What are the storage conditions for feed materials and Schedule 5 products? (Note 15)

Note 15. Outline the storage conditions for feed materials and Schedule 5 products, e.g. barley stored in clean, dry conditions at ambient temperature in silo number 1; liquid-Starch stored in external 5000 litre metal storage tank; vitamin/mineral supplements containing ‘Medicine’ stored on pallets in locked feed store; etc


SECTION H. RECORD-KEEPING

Requirement:

Manufacturers must keep intake details of all Schedule 5 products, their use in the manufacture of other products, and the supply of such products, to enable effective tracing from receipt to delivery. All records must be kept for a minimum of 5 years

Manufacturers must also have a HACCP plan, setting out the critical control points in the manufacturing process; and a Quality Control plan, setting out the relevant controls. Results of controls must be kept.

Records should be kept detailing all relevant events that occur in relation to the manufacture of Schedule 5 products. For simple manufacturing operations, a “Feed Log” in the form of a page-a-day desk diary is useful for the purpose. Records should be kept clean and free from rodent activity, and should be available for inspection by the enforcement authority.

Recording Instructions:

1. The record of all cleaning carried out under section D will be made in/on ……………………..

2. The record of pest control measures will be kept in/on ………………………………………………

3. Records of all feed incoming feed materials and Schedule 5 products, showing the supplier, product details, quantity, date and batch identification (where relevant) will be kept for 5 years in/on………………………………………………………..

(NB where those details are recorded on a Supply Note, those records may be kept).

4. Manufacturing (production) records will be kept, showing the date, type and quantity of Schedule 5 products manufactured; and the name, quantity and batch number of other Schedule 5 products used in that process. These records will be made in/on…………………………………………………...

5. (For those manufacturers supplying medicated premixtures/feedingstuffs to livestock keepers): A valid MFS prescription (MFSp) must be obtained before supplying a medicated premixture or feedingstuff to a keeper of animals. All instructions on the MFSp will be complied with. All MFS prescriptions must be retained for 5 years.

6. (For those manufacturers producing medicated feed solely for feeding to their own livestock):A valid MFS prescription (MFSp) must be obtained before commencing manufacture of a medicated feedingstuff. All instructions on the MFSp will be complied with. All MFS prescriptions must be retained for 5 years.

7. The supply of SFAs and premixtures containing VMPs/SFAs must only be made to premises appropriately approved for the manufacture of feedingstuffs containing such products. A Register of Approved Feedingstuffs Manufacturers and Distributors is published on the VMD website: www.vmd.defra.gov.uk


http://www.vmd.defra.gov.uk/

SECTION I. COMPLAINTS & RECALL

Requirement:

Manufacturers who supply Schedule 5 products must implement a system for registering and processing complaints.

Manufacturers who supply Schedule 5 products must document and put in place a system for the effective recall of products in the distribution network; and the procedure for dealing with recalled products.

1. A copy of the Complaints & Recall procedures are attached/filed in/set out below:

……………………………………………………………………………


Appendix 1 – Record of Review of Documented Procedures & HACCP Plan

Date of Review

Reviewer Reason for Review Changes Made


Appendix 2 QUALIFIED PERSONS

QUALIFIED PERSONS FOR FEEDINGSTUFFS PRODUCTION (QPFP)

A QPFP is responsible for ensuring that:

the different stages of production are carried out according to pre-established written procedures and instructions aimed at defining, checking and monitoring the critical points in the manufacturing process;

technical or organisational measures are taken to avoid or minimise, as necessary, any cross-contamination and errors. There must be sufficient and appropriate means of carrying out checks in the course of manufacture;

the presence of prohibited feed, undesirable substances such as banned or non-authorised medicinal products, antimicrobial growth promoters, coccidiostats and histomonostats, and other contaminants in relation to human or animal health are monitored, and appropriate control strategies are put in place to minimise risk;

waste and materials not suitable as feed are isolated and identified and any such material containing hazardous levels of veterinary drugs, contaminants or other hazards are disposed of in an appropriate way and not used as feed;

adequate measures are taken to ensure effective tracing of the products.

QUALIFIED PERSON FOR FEEDINGSTUFFS CONTROL (QPFC)

A QPFC does not necessarily have to work on site or be part of the business. A QPFC is responsible for ensuring that:

as part of a quality control system, they have access to a laboratory with adequate staff and equipment.

a quality control plan is drawn up in writing and implemented, to include, in particular, checks on the critical points in the manufacturing process, sampling procedures and frequencies, methods of analysis and their frequency, compliance with specifications – and the destination in the event of non-compliance – from processed materials to final products.

documentation relating to the raw materials used in final products is kept in order to ensure traceability and that the documents are available to the competent authorities during periods that are appropriate for the use for which the products are placed on the market.

samples of ingredients and of each batch of products manufactured and placed on the market or each specific portion of production (in the case of continuous production) are to be taken in sufficient quantities, using a procedure pre-established by the manufacturer, and retained in order to ensure traceability (on a regular basis in the case of manufacture solely for the manufacturers own needs). The samples must be sealed and labelled for easy identification and stored under conditions that prevent any abnormal change in the composition or the sample or any adulteration. They must be kept at the disposal of the competent authorities for a period appropriate to the use for which the feed in placed on the market. In the case of feedingstuffs for animals not kept for food production, the QPFC only has to keep samples of the finished product.

Hazard Analysis of Critical Control Points (HACCP) Plan


Introduction:

HACCP is a structured approach to analysing the potential hazards in an operation, and deciding those points whose control is critical to ensure the product meets established quality and customer safety criteria. There are 7 key steps in a HACCP analysis;

1. Identify the potential hazards at all stages in the production process up to the point of consumption and assess the likelihood of occurrence of the hazards and identify the preventative measures needed for their control.

2. Determine the critical control points (CCPs). Identify the procedures and operational steps that can be controlled to eliminate or minimise the likelihood of their occurrence.

3. Establish critical limits. Set target levels and tolerances that must be met to ensure the CCP is under control.

4. Establish a system to monitor the CCPs.

5. Establish corrective actions to be taken when monitoring indicates a particular CCP is not under control.

6. Establish verification procedures to confirm that the HACCP system is working correctly.

7. Establish documentation concerning all procedures and records appropriate to these steps and their application.

A hazard is “the potential to adversely affect product quality or the potential for non-conformance”.

A CCP is “any point, stage or function where control is necessary to maintain product quality”.

Implementing a HACCP system

1. Form a HACCP team

2. Identify the processes involved with the manufacture of feedingstuffs (see Section E part 1)).

3. Describe the products manufactured (See Section B part 1).

4. Define the Product Quality Criteria and Usage (See Section E part 2).

5. Produce a flow-chart for the process. This is a basic line diagram for each step in the process, and should include every point, stage, machine and manual operation within the process from raw material intake to product despatch. A sequential number should be assigned to each step (see example HACCP Appendix A).

6. Identify and assess potential hazards in the process. Identify any hazard that will affect the items on the Product Quality Criteria checklist. Any such hazard should be recorded on the Hazard analysis sheet (see example HACCP Appendix B). If there


is no hazard in respect of a process step, it should be recorded as ‘none’. Each hazard should be assessed for its likelihood of occurrence (the frequency) and the level of risk associated with each hazard. For frequency, a value of 3 indicates a high likelihood of occurrence, 2 is a medium likelihood and 1 is a low likelihood. For risk, a value of 3 indicates a high degree of risk, 2, a medium degree of risk and 1 a low degree of risk.

7. On the hazard analysis sheet, record what control measures are in place and determine the ‘catastrophe’ potential for each hazard by multiplying the frequency value by the risk value. The higher the result, the greater the potential for a ‘catastrophe’ to occur.

8. From the highest catastrophe scores identify the CCPs by deciding:(a) is control needed at this point to prevent a risk to either food or feed safety; and (b) is the risk controlled at a later step.If the answer to (a) is YES and the answer to (b) is NO, then the step is a CCP and failure to control this point could lead to a food or feed safety issue. Sequentially number each CCP on the hazard analysis sheet.

9. Complete the process specifications (See example HACCP Appendix C) for each CCP. These identify what test is to be performed, how frequently it is to be done, what levels are acceptable, where the results are to be recorded, who is responsible for carrying out the test and what action is to be taken if the result is outside the acceptable limits.

10. Produce documentation for the system:

- written work instructions;- detailed specifications for products;- appropriate documentation for recording test results and parameters.

11. Review the system. This should be done with all plant operators to ensure they are aware of their responsibilities.

12. Trial the system. Try the system for a period e.g. 1 month.

13. After trialling the system, review and amend where necessary. This should be done in collaboration with those operating the system, and all views should be heard and feedback encouraged. Any changes suggested should be considered and adopted wherever possible, given no detrimental effect on the level of control.

14. Monitor and maintain the system. Regular monitoring of the tests performed will ensure adherence to the CCPs. Any CCPs not being performed as required should be investigated to identify the reason for failure.

A formal review should take place at least annually or whenever a significant change is made to the plant or operating conditions.

HACCP APPENDIX A - Flow-diagram for a typical feed-manufacturing process (example)


Raw Materials

Bagged RM Vet Medicine Bulk Intake (1) Blow Line (7) storage (5) storage (6)

Elevator (2) MFS Prescription (8)

Conveyor (3)

Storage Bins (4)

Weigh/Measure (9) Weigh (9) Weigh/Measure (9)

Grinder (10)

Blow Line (7)

Hand Tip (11) Cyclone (12) Dust Sacks (13)

Mixer (14)

(19) Bagging Point Two-way valve FP Elevator (16) (15)

(20) Bagged FP storage FP Conveyor (17)

FP Bins (18)


HACCP APPENDIX B. HAZARD ANALYSIS SHEET (example)

Process No.

Process Step Hazard Frequency Risk Catastrophe Potential

Control Measures CCP

1 Bulk Intake 1.1 Presence of foreign bodies e.g. stones 2 3 6 Screen 1

1.2 Presence of harmful micro-organisms (e.g. Salmonella)

3 1 3 Routine cleaning

2 Elevator None

3 Conveyor None

4 Bulk Storage 4.1 Spoilage of feed materials due to growth of micro-organisms

2 3 6 Routine cleaning 2

4.2 Pest damage 2 1 2 “5 Bag Storage 5.1 Pest damage 2 2 4 Routine cleaning and

baiting

6 Vet Medicine storage

6.1 Security 1 2 2 Use locked storage area.

7 Blowline None8 MFS

prescription8.1 No current MFSp8.2 Insufficient tonnage on prescription

2 2 4 Check dates, levels and tonnes produced

9 Weighing 9.1 Incorrect weighment 2 3 6 Calibrate 6 monthly 3

10 Grinding 10.1 Incorrect grist size 2 2 4 Visual & Screen

11 Hand Tip 11.1 Contamination 2 2 4 Visual clean before use

12 Cyclone None

13 Dust Sacks 13.1 Contamination 2 1 2 Empty regularly

14 Mixer 14.1 Poor mixing 2 3 6 Mixing time/ efficiency checks

4

14.2 Cross-contamination 2 3 6 Scheduling 5

15 Diverter None

16 FP Elevator 16.1 Contamination 2 3 6 Scheduling 5

17 FP Conveyor 17.1 Contamination 2 3 6 Scheduling 5

18 FP Bins 18.1 feed sent to wrong bin 1 2 2 Check bins

19 Bagging Point None

20 FP Bags 20.1 Product identification 2 2 4 Label bags


HACCP APPENDIX C - Critical Control Points – Specification (example)

CCP Process Step Hazard and cause

Control Measure

Limits Monitoring procedures (who, what, when)

Recorded Corrective Action

1 Bulk Intake Microbial contamination

Routine Cleaning

No visual contamination

Mill operatorto check bulk intake;

weekly

Feed Log Follow Cleaning Instructions 1c

2 Bulk Storage Spoilage due to build up in

bin

Routine Cleaning

No visual contamination

Mill Operator to check bulk storage; annually

Feed Log Follow Cleaning Instructions 1c

3 Weighing Incorrect weighment

Calibration of weighing

equipment

<1% deviation Manager to calibrate all weighing equipment;

6 monthly

Feed Log Review frequency of calibration

4 Mixing Poor mixing Correct time/ addition of materials

CV<10% Manager and QPFC to conduct mixer trial;

6 monthly

Production & QA records

Amend mixing process until required CV

achieved.

5 MixingFP Elevator

FP Conveyor

Contamination Scheduling Nil carryover into successive feed

batch

Manager and QPFC to conduct carryover trial;

6 monthly

Production & QA records

Amend scheduling/cleaning procedure until nil carryover

achieved


Flow Diagram of Manufacturing Process: (see example – HACCP Appendix A)


HAZARD ANALYSIS SHEET (see example – HACCP Appendix B)

Process No.

Process Step Hazard Frequency Risk Catastrophe Potential

Control Measures CCP


Critical Control Points - Specification (see example – HACCP Appendix C)

CCP Process Step Hazard and cause

Control Measure

Limits Monitoring procedures (who, what, when)

Recorded Corrective Action


Notes


Documents

Guidance for Manufacturers of Feedingstuffs containing ... file · Web viewThese documented procedures and HACCP plan should be reviewed on an annual basis or whenever a significant