Title Page
-
D 1703
-
Supplied Visit / Verification Checklist to HACCP & GMP
-
Client / Site
-
Conducted on
-
Prepared by
-
Location
-
Personnel
-
Supplier Visit / Verification Checklist to HACCP & GMP
0.1 Concerns from the visit
-
Add Corrective Actions
-
Corrective Action
0.2 Outstanding Actions from Third Party Audits / Visits noted as a concern?
-
Outstanding Actions noted
-
Outstanding Action
1 Feed Hazard Risk Assessment
-
1.1 Has a site food safety risk assessment been done
-
1.2 Does the risk assessment use HACCP principles
-
Feed safety elements
- flow charted
- Uses HACCP principles
- has all elements, team, scope, product description, sensitive customers, process flow chart, hazard analysis, critical points, monitoring systems, corrective action for deviation, verification process,
- identifies risks
- provides for the management of the risks
- has verification of risk management
- regularly reviewed
2 Premises and buildings
-
2.1 Site plan available
-
Site plan elements
- major buildings identified
- storage areas identified
- processing areas identified
- chemical storage identified
- hazardous goods identified
- pest control bait stations identified
-
2.2 Does the site have suitable drainage
-
2.3 Are roadways maintained in good condition
-
2.4 Are grounds machinery and buildings cleaned regularly
-
2.5 Any non-RAM products made on site if so are there seperate receival hoppers
-
RAM Elements
- separated receival hoppers
- written procedures for joint receival hoppers
- flushing procedures in place
- flushing procedures verified
-
2.6 Is there a written cleaning procedure in place
-
Cleaning procedure elements
- regular cleaning records
- areas assigned to staff
- Records completed
- Supervisor checked and confirmed
- Visual appearance matches records
-
2.7 Is site security sufficient to stop accidental or deliberate contamination
-
Security elements
- unauthorised access to site
- access to chemicals controlled
- receival pits screen/covered secure and locked
-
2.8 Are there written procedures controlling both visitors and contractors entering the site
-
2.9 Is there a written procedure to make all visitors aware of their potential impact on product safety, quality and the environment
-
2.10 Is there a written and documented pest control program
-
Pest control program elements
- covers rodents
- regular bait station checking
- covers birds
- covers insects
- covers weeds
- management review and adjustment of actions to pest activity levels
- routinely reported t
-
2.11 Is waste and contaminated material regularly removed from site
-
2.12 Is waste and contaminated material controlled
-
Waste control elements
- waste containers clearly marked
- waste and process materials cannot be accidentally mixed
-
2.13 Can raw materials or finished goods be unloaded / loaded in the rain without significant water damage (mold growth?)
-
rain and water damage mitigation elements
- Steps taken to minimise rain damage
- little or no perceived risk to materials and products
-
2.14 Is ventillation adequate
-
Ventillation elements
- steam air moisture (mold) accumulation controlled
- dust accumulation controlled
- airborne contaminats controlled
3 Personnel
-
3.1 Are personnel suitable to the task
-
3..2 Are employees provided with written duties
-
Personnel elements
- qualified or experienced
- have written duties
- have a job descrition
- have work procedure and/or work instructions
- training records up to date
-
3.3 Are employees trained in GMP as it relates to their duties
-
3.4 Is there a training program in place
-
Documented in employee records
- Specific GMP training records
- RAM training included
- FeedSafe knowledge sound
- Medication control understood
- General training satisfactory
- Records up to date
-
3.5 Are maintenance staff trained to identify equipment faults which impact upon product quality and safety
4 Plant and Equipment
-
4.1 Is the design and construction appropriate to meet the requirements
-
Pant and equipment elements
- Silo or bin clearly and uniquely identified
- drivers record bin/silo deliverd
- when customer changes bin delivery this is recorded
- Spillages are reported back to base and steps taken to rectify
- truck compartments inspected for completion of unloading
- system in place to coordinate delivery vehicles in a biosecurity breach or disease outbreak
- Customer quarantine and biosecurity measures known and adhered to by drivers and mill staff
-
4.2 Is the equipment designed and maintained to prevent contamination during the manufacturing process
-
Equipment design elements
- sound condition
- minimal leaks
-
4.3 is there appropriate dust extraction on equipment
-
4.4 Is equipment designed and installed to allow for routine cleaning, mainteance and inspection.
-
4.5 Is a preventative mainteance program in use
-
Preventative Maitenance elements
-
4.6 Are monitoring and/or controlling devices monitored for accuracy and recalibrated when required
-
Monitoring devices elements
- includes weight scales
- includes trade certified measurement
- includes high temp probes
- includes low temp probes
- includes flow meters
- includes gas meters
- includes lifting chains
- includes calibration accuracy
- includes correct calibration frequency
- includes records of external calibration
- includes records of internal calibration
-
4.7 Do appropriately trained personnel carry out the maintenance and calibration of equipment
5 Raw Materials sourcing and pricing
-
5.1 Is there as documented purchasing program for the purchasing of raw materials and packaging
-
Purchasing program elements
- Uses raw material purchasing standards
- reflects treatment and/or withholding periods
- Suppliers aware of the standards
-
5.2 Is every load of incoming material cross referenced to purchasing documentation
-
5.3 Does the site maintain a register of compliant raw material suppliers
-
Register elements
- suppliers list linked to QA program
- provision of vendor declarations
- DIFOT monitored
- agreement to specification monitored
6 Raw Material receivals
-
6.1 Is every load of incoming raw materials cross referenced to purchasing documentation
-
6.2 Is a record of origin, date of receipt, quantities of each raw material kept on file
-
6.3 Does the site have a written raw material quality control program
-
Raw Material QC program elements
- sampled
- tested
- confirmed against specifications
-
6.3.1 Are suitably trained or experienced staff assigned to raw material receivals
-
6.3.1 RM receivals elements
- Correctly identified
- Sampled
- Tested
- Confirmed against specification
-
6.3.2 Are the recieval tests appropriate
-
6.3.2 Receival test elements
- grains
- soft meals
- processed goods
- pacaking materials
- Micro ingredients
-
6.3.3 Are retentions samples taken and kept for at least three months
-
6.3.3. Retention sample elements
- HACCP linked
- supplier history linked
- Stored adequately for preservation
- greater than 3 months
- externally tested (composite)
- externally tested ( individually)
- retention samples ID includes date
- retention samples ID includes material ID
- retention samples ID includes weighbridge number
-
6.3.4 All packaged raw materials are adequately labelled
-
6.3.4 labelling elements
- feeding ban ( RAM statement)
- non- RAM statement
- Identity clear
- supplier ID clear
- shelf life stated
- packaging appropriate to contents
- medications clearly identified
-
6.3.5 are labelling and packaging materials assessed for quality before use
-
6.4 Are raw materials found to be outside specification clearly identified and appropriately dealt with by authorised personnel
-
6.3.5.1. Are labels or tickets stored securely with use adequately controlled
-
- Labels uniquely numbered
- Issue of labels controlled
- return of labels controlled
- Stored to prevent cross mixing
- version and ID control in place
-
6.3.5.2. Are bags stored securely with use adequately controlled
-
- Stored to prevent cross mixing
- Issue cotrolled
- returns controlled
7 Raw Material Storage
-
7.1 Are storage areas designed and maintained to prevent damage to, contamination, unintended mixing, or spoilage of ingredients or packaging materials
-
7.2 Are storage bins, silos, tanks, and storage areas clearly identifed
-
7.2 Storage ID elements
- Clearly Identifed
- unique ID
- written documentation of contents of each storage vessel within the facility
-
7.3 Is there an inspection and maintenance programme for storage silos, bins, tanks, which prevents raw material quality being compromised
-
7.3 Storage vessel elements
- Documented
- vessels have regular pattern of being emptied and inspected
- spot checks at stock take
-
7.4 Are all packaged raw materials stored adequately allowing separation of different raw materials
-
7.4 raw material storage elements
- multi level racking in place
- first in first out stock rotation
- visually confirmed as stored separately
-
7.5 Are storage areas clean and tidy and have steps been taken to minimise vermin and bird presence
-
7.5 Storage areas elements
- clean
- tidy
- gaps between pallets and walls for vermin deterrent
- bird deterrents in place
- RAM in a designated area
-
7.6 are feed additive ( and medications) clearly identified and stored in accordance with labels ( or regulations)
-
7.6 feed additive and medication storage elements
- temperature matched
- humidity matched
- secure area
- cross contamination controls in place
- dispensing area handling tailored to materials
- medications kept in locked secure area
8 Products / agents on site not used in feed storage, handling or use
-
8.1 Are hazardous materials such as pest control baits, boiler chemicals, fuel, cleaning agents stored securely away from ingredient handling areas to prevent mistaken use
-
8.1 Non Manufacturing chemical materials elements
- Stored close to intended use
- stored securely
- labelled and or clearly identified
- Usage recorded
-
8.2 Are Pest control chemicals controlled
-
8.2 pest control elements
- Use controlled and recorded
- If stored on site, storage secure
-
8.3 Are cleaning agents controlled
-
8.3 cleaning agents control elements
- use controlled and recorded
- secure storage area
- record of cleaning agents used on site
-
8.4 Is there any form of inventory controll system for non-manufacturing chemicals
-
8.5 Are all non-ingredient materials managed to ensure they are not mistakenly incorporated into product
-
8.5 non-ingredient chemical elements
- use controlled and recorded
- secure storage area
- record of cleaning agents used on site
9 Formulation and manufacturing instructions
-
9.1 Is there a written formulation master file
-
9.1 Master file elements
- record of dates of use
- version controlled
- maintained by an authorised person
-
9.2 Do the formulas meet the needs for audit trails
-
9.2 Formula elements
- name of product
- unique identity code
- animal type to be fed
- precise quantity of each raw material
- location raw material drawn from
- identifies RAM products from non-RAM products
-
9.3 Formulation changes done by and authorised person and these are documetned
-
9.4 is there a written procedure to prevent cross contamination of feeds with incompatible feed ingredients that is verified through inspection, sampling and testing
-
9.5 Are precautions taken to prevent cross contamination of finshed mixes/products
-
9.5 cross contamination elements
- flushing in place
- sequencing used
- cleaning at key changeover points
-
9.6 Is there a procedure for the labelling, storage, and handling of reworkes and returns
-
9.6 rework elements
- status labelling applied
- identity labelling applied ( e.g NCR number)
- bag reworks sealed
- seperated storage
- when classifed waste this is clearly identified
- RAM and Non-RAM separated
- target for reprocessing into like product ( food safety wise)
- reformulated by authorised person
- rework and return policy, procedure or task instruction documented
10 Production
-
10.1 Are there written work instructions for the critical manufacturing process jobs
-
10.1 Work instruction elements
- connects to CCP in HACCP
- instruction or records when process departs from defined procedure
- Work instructions and manufacturing procedures regularly reviewed
-
10.2 Are veterinary chemical products in use registered by the APVMA and dispensed according to veterinary prescription
-
10.3 Are veterinary prescriptions kept on file
-
10.3 Vet script elements
- no more than 6 months cover
- veterinary license stated
- dosage stated
- start date stated
- archived for one year once lapsed
- Vet license to practice routinely checked
-
10.4 are batching records kept to show product made to formulation
-
10.5 Are there specified material weighing tolerances and are these monitored
-
10.6 Are there records to confirm the mixer has been tersted for mixing efficiency in the past 12 months
-
10.7 Are production records kept for at least 12 months
-
10.8 Are out loading and packaging systems including Silos, bins and tanks designed and operated to maintain separation of finished product
-
10.8 Bins and Silos elements
- Identified with unique ID or numbering
- clear identification of what is stored in tanks, silos or bins
- silos and bins cleaned and maintained to keep quality integrity
-
10.9 Are clearly labelled finished product samples taken and retained for at least three months
-
10.10 Is the person doing the production supervisor and/or manager's role appropriately trained
11 Labelling of Bagged Product
-
11.1 Are bagged finished goods correctly packaged and labelled at the time of manufacture
-
11.1 Bagged goods elements
- bag used identified
- bags properly sealed
- where applicable, label is secured without damage to regulatory controlled statements
- labels clear in print quality
- Date of manufacture stated
- shelf life stated
- batch coded
- if applicable RAM and non-RAM statement evident
- bags check weighed
- label if used identified
- if needed flushing procedure in place
- in process routine QC/QA tests done
- if used label numbers are reconciled
- bags numbers are reconciled
- bagging are free of foriegn bags or other jobs
- Directions for use evident on bag or label
- if present medications and dosage identified
- if present regulated key trace elements and amounts identified
12 Labelling of Bulk Product
-
12.1 Does the bulk delivery docket/invoice documents meet regulatory requirements
-
12.1 Bulk goods elements
- Name of customer identified
- product clearly identified
- RAM statement included
- when used appropriate medication statement included
- Audit trail, outload silo, truck bin, customer silo is robust
- Delivery date stated
- Other regulatory statement requirements met
- sample taken with ODD, date, product and customer clearly identified
- Samples taken are stored for at least 3 months
13 Loading, transport and delivery
-
13.1 are there loading and delivery procedure for loading bulk and bagged products which ensures loading the delivery vehicles with the correct product without risk of damage, unintended mixing, or contamination
-
13.2 Is there a formal system of allocating finished product orders to outloading bins and delivery vehicles
-
13.2 delivery vehicle loading elements
- Outloading bins clearly identified
- transport vehicles and compartments clearly identified
- inspected for residue if carried different products previously
- cleaned and/or flushed and this is recorded if swapping from RAM to non-RAM or other incompatible products in bins or tanks
- external carrier previous load carried ( and if needed cleaning) confirmed
- Pallets are checked prior to use to ensure they are in good condition and checking recorded
- Broken, damaged, part filled finished products dealt with to ensure not delivered nor can cross or be cross contaminated
-
13.3 Are delivery vehicles kept in a clean well maintained roadworthy condition, designed so feeds are kept dry and protected from contamination
-
13.3 Delivery vehicle elements
- Loads covered during delivery
- drivers documents identify products, bin allocation, precise delivery address, site delivery bin to be placed
- If feed contaminated due to an incident/accident, there is a system for reporting, determining follow up actions for delivery, return or disposal
- Vehicles clean
- Pallet transport free from dirt
-
13.4 Feed delivery, clients reminded of responsibility to provide safe and unobstructed facilities
-
13.4 Feed delivery elements
- Silo or bin clearly and uniquely identified
- drivers record bin/silo deliverd
- when customer changes bin delivery this is recorded
- Spillages are reported back to base and steps taken to rectify
- truck compartments inspected for completion of unloading
- system in place to coordinate delivery vehicles in a biosecurity breach or disease outbreak
- Customer quarantine and biosecurity measures known and adhered to by drivers and mill staff
14 Inspection Sampling and Testing
-
14.1 Are key staff aware of requirement to allow unhindered access to state authorities for sampling and auditing to TSE ruminant feed ban
-
14.2 Is sampling of finished product conducted so that samples are sealed, separated, retained for easy retrieval, in appropriate conditions or preservation
-
14.3 Is sample testing adequate
-
14.3 Sample testing elements
- on site with appropriately trained and equipped staff
- off site from reputable (e.g.NATA) laboratory and certified practitioner
- inspection results assessed against documented tolerances or standards
- outside of specification tolerances has method and responsibilities in place for investigations and corrective actions
15 Records
-
15.1 Are records kept to allow finished product trace back for 12 months or more
-
15.1 Record elements
- includes raw materials source and storage
- includes production batching
- includes product quality test results
- includes delivery details
- includes verified flushing and sequencing
- Includes mixing efficiency
16 Customer Complaint Investigation
-
16.1 Is there a customer complaint procedure for registering and investigating problems
-
16.2 Is there a record of timely resolution of complaints with appropriate corrective and preventative actions
-
Is this timeliness of resolution consistently applied for all complaints where possiblet
17 Product recall system
-
17.1 Is there a recall committee with clearly defined memebers and documented responsibilites
-
17.2 Is there a written product recall procedure and is this linked to tte customer complaint procedure
-
17.3 Does the recall procedure call for; prompt retrieval from the market place, notification of relevant government authorities, minimisation of disruption ot end users.
-
17.4 does the recall procedure apply in other cisrumstances like out of specification products
-
17.5 Does the recall procedure specify methods to identify, locate, and return/isolate/control recalled product
-
17.6 Does the recall procedure include emergency out of hours contact person/people
-
17.7 Is the recall system periodically reviewed/tested for effectiveness
-
17.8 Is each recall incident documented and reviewed to ensure procedure was adequate with a review of manufacturing practices to ensure they prevent reoccurrance
Other Observations or Comments
-
Observation / Comment
-
Observation
-
Signature of Chris Edwards