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Documented Procedures & HACCP Plan
Guidance for Approved Distributors of Schedule 5 Products
# Last updated October 2011
Introduction:
The procedures laid down in this document are intended to assist approved Distributors of specified feed additives (SFAs*), premixtures and complementary 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 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 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.
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Section A. Establishment & Personnel Details
Requirement:
Feed business operators who stock, supply or distribute Schedule 5 products are required to be approved as Distributors 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.
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Section B. Feed Details
1 What is the nature of the business? – (Note 2).
2 What Schedule 5 products are distributed/stored/supplied? (Note 3)
3 Are the premises certificated by an Assurance Scheme (provide details)?
Section C. PERSONNEL
Designated Person (Note 4)
Note 2. List the activities involving Schedule 5 products e.g. medicated feed is re-packaged, stored, dispatched from store to customer or dispatched from manufacturer direct to customer.
Note 3. Specify the types of Schedule 5 products; e.g. game feeds, medicated pig minerals, medicated molassed buckets
Note 4. The Designated Person is the person who is normally responsible for all issues relating to the distribution/storage/supply of controlled products, including complaints and recall procedures.
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Details of the designated person’s role & responsibilities; and qualifications and/or experience
Section D. Facilities & Equipment
Requirement:
All parts of the premises used for the 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.
If applicable, weighing scales and metering devices used in the repackaging of Schedule 5 products must be appropriate for the range of weights and volumes to be weighed/measured and must be regularly calibrated. 1. Indicate the cleaning programme for the premises and equipment (Note 5)
2. Indicate the pest control measures taken for the storage areas and equipment (Note 6)
Note 5. Outline the cleaning requirements for the facilities and equipment e.g. (i) Daily – All spillages will be cleaned up and safely disposed of. (ii) Weekly - Bag storage areas will be cleaned up.(iii) Annually - The fabric of the building(s) and storage areas will be thoroughly cleaned. Bulk bins and
storage areas will be treated for mite & insect infestation, following all Health & Safety guidelines.
Note 6. Outline the pest control policy for the storage areas, including a diagram of the premises showing the location of bait control measures.
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Section E. Repackaging
Requirement
Where repackaging is carried out, all stages of the process 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 repackaging.
Repackaging premises must have measures in place to ensure effective tracing of the products.
Ultimately, repackaging premises 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 repackaging of Schedule 5 products? (Note 7).
Note 7. Outline the processes used in the repackaging of Schedule 5 products, e.g. feed hopper checked for cleanliness, tote bags of feed emptied into hopper, feed directed into 25kg bags via chute and bags weighed and labelled. A flow diagram of these processes will be required for the HACCP plan.
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Section F. Quality Control
Requirement:
Where repackaging is carried out quality control measures must be followed to ensure that the product specification of repackaged Schedule 5 products is maintained.
Repackaging premises must have a Quality Control (QC) plan which includes, in particular, checks on the critical points in the repackaging process, sampling procedures and frequencies, methods of analysis and what controls are in place to deal with non-complying products. The QC plan should be drawn up in conjunction with the Designated Person.
Appropriate records must be kept to permit the tracing of all Schedule 5 products from intake to delivery, and of each batch repackaged.
A readily identifiable sample from each batch of repackaged product must be retained for an appropriate period, being at least the shelf life of the product.
Quality Control Plan:
1. All weighing and metering equipment must be calibrated or checked as set out below:
2. What checks are carried out to ensure that Schedule 5 products are of suitable specification? (Note 8)
Note 8 Indicate the checks that will be made on Schedule 5 products e.g. only purchased from assured manufacturers, any product testing etc.
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SECTION G. STORAGE & TRANSPORT
Requirement:
Schedule 5 products 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 and transport conditions for Schedule 5 products? (Note 9)
Note 9. Outline the storage conditions e.g. all products dispatched direct from manufacturer, Schedule 5 products kept in segregated area of warehouse, or medicated products stored in locked cage in main building.
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SECTION H. RECORD-KEEPING
Requirement:
Distributors must keep details of purchase of Schedule 5 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
Distributors must also have a HACCP plan, setting out the critical control points in the supply process; and if applicable, 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 distribution/supply of Schedule 5 products. A ‘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 VMD.
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 incoming 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. Where appropriate, repackaging records will be kept; showing the date, type and the quantity of Schedule 5 products repackaged; and the name, quantity and batch number of the Schedule 5 products supplied. These records will be made in/on…………………………………………………...
5. 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. The retail 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
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SECTION I. COMPLAINTS & RECALL
Requirement:
Distributors who store/supply Schedule 5 products must implement a system for registering and processing complaints.
Distributors who store/supply Schedule 5 products must document and put in place a system for the effective recall of such 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:
……………………………………………………………………………
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Appendix 1 – Record of Review of Documented Procedures & HACCP Plan
Date of Review
Reviewer Reason for Review Changes Made
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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/distribution 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/distribution of Schedule 5 products (see Section E part 1)).
3. Describe the products manufactured/distributed (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 product intake to product despatch. A sequential number should be assigned to each step (see example HACCP Appendix A).
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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 1a 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 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 staff involved in the storage and supply of Schedule 5 products 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 premises or operating conditions.
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HACCP APPENDIX A - Flow-diagram for a typical distribution process (example)
Customer Order (1)
Specification Control (2)
Prescription Control (3)
Order Prescription (4)
Product Ordered (5)
Product Intake(6)
Product Storage (7)
Product Allocated (8)
Product Delivered (9)
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HACCP APPENDIX B. HAZARD ANALYSIS SHEET (example)
Process No.
Process Step Hazard Frequency Risk Catastrophe Potential
Control Measures CCP
1 Customer Order
Incorrect order taking 1 2 2 Repeat order to customer
Non-approved premises orders a premixture containing a VMP/SFA
1 3 3 Approved manufacturers Register checked
2 Specification Control
Change to existing product 2 2 4 Obtain new specification
3 Prescription Control
Feedingstuff contains a POM product 2 2 4 Check prescription available before supply
Prescription expired 3 1 3 Check dates, obtain new prescription
Tonnage level on prescription already supplied 2 2 4 Check tonnage, obtain new prescription
4 Order Prescription
Incorrect inclusion rate/product type requested 1 3 3 Confirm product and levels with prescriber.
5 Product Ordering
Incorrect Product ordered 2 3 6 Confirm orders with supplier
1
6 Product Intake Non-conforming product supplied 1 2 2 Inspect all deliveries for evidence of contamination, damage or errors.
7 Product Storage
Pest Damage 2 3 6 Routine cleaning and pest control implemented
2
Cross Contamination 1 2 2 Segregation of controlled products
8 Product Allocated
Non-conforming product allocated 2 2 4 Product checked for evidence of damage or contamination, date expired or incorrect product type
9 Product Delivered
Delivery prior to prescription being received 3 2 6 Delivery control procedure
3
Product delivered to wrong address/location 2 1 2 Delivery note details and instructions
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HACCP APPENDIX C - Critical Control Points – Specification (example)
CCP ProcessStep
Hazard and cause
Control Measure
Limits Monitoring procedures (who,
what, when)
Recorded Corrective Action
1 Order Prescription
Incorrect inclusion rate/product type requested
Confirm product and levels with
prescriber.
No errors Customer Services Dept. Check every
Order
Customer Order Records /
Prescription file
Supply delayed until valid prescription
obtained
2 Pest Damage
Spoilage, disease, faecal contamination
Check all products on intake and before supply
No obvious damage
Warehouse staff Feed Log Book Quarantine products for disposal
3 Product Delivered
Delivery prior to prescription being received
Delivery control procedure
No errors Customer Services Dept. Check every
Order
Customer Order Records
Supply stopped. Valid prescription obtained
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Flow Diagram of Manufacturing Process: (see example – HACCP Appendix A)
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HAZARD ANALYSIS SHEET (see example – HACCP Appendix B)
Process No.
Process Step
Hazards Frequency Risk Catastrophe Potential
Control Measures CCP
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Critical Control Points - Specification (see example – HACCP Appendix C)
CCP Process Hazard and cause
Control Measure
Limits Monitoring procedures (who, what, when)
Recorded Corrective Action
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Notes
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