1 |
A Food/Feed Safety policy has been defined, reviewed and implemented by top management. Has the policy been communicated to each employee? |
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2 |
Document control procedures are in place, and documents are accessible to appropriate personnel. |
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3 |
The physical and chemical Feed Safety Hazards in the AFIA Hazard Guide have been identified, reviewed, and have control procedures, where applicable. |
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4 |
Records retention procedures are defined and followed. Records must be maintained for one year from date of manufacture of finished product or receipt of ingredients. |
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5 |
The following records are maintained as appropriate to the product: (BSE feed rule, medicated feed, formula/mixing instructions, production records, drug assays, and label files). |
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6 |
Responsible personnel review the following: audit results, customer feedback, process performance and product conformity, status of preventive and corrective actions, follow-up action from previous management reviews, planned changes that could affect the food/feed system and recommendations for improvement.). |
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1 |
Personnel are competent for assigned tasks and received initial training and at least annual recertification. |
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2 |
Job descriptions are maintained that include the responsibility and skills required by the employee to complete the job. The employee is evaluated to determine knowledge of the required skill. |
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3 |
Personnel are properly trained in SOP's for restricted areas, and where appropriate, to avoid contamination or carryover from internal or external sources. |
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1 |
A team has been formed to identify, evaluate, and control feed and food safety hazards. |
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2 |
Check points where hazards may enter the facility are identified and controlled. |
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3 |
Verification, monitoring, inspection, and test activities have been determined specific to the need of the product. |
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1 |
Records are maintained for each product which includes the supplier approval process, product specifications, formulation, label, and special manufacturing instructions. |
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2 |
Procedures exist to monitor and measure the manufacturing processes. |
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3 |
Procedures exist and are implemented to compare expected and theoretical results and to reconcile any differences. [see section J.] |
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1 |
Monitoring procedures have been established to evaluate incoming raw materials and finished products, where appropriate. |
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2 |
Scheduled monitoring activities have been established and should include incoming raw material evaluation and finished product evaluation. |
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3 |
Ingredient and finished product assays are performed on a scheduled basis, where appropriate. |
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4 |
Check points where hazards may enter the facility are indentified and controlled. |
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5 |
Verification, monitoring, inspection, and test activities have been determined specific to the need of the product. |
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1 |
Procedures exist for the review and evaluation by the feed safety team of feed and food safety hazards in the event of new or changed facilities or equipment. |
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2 |
Buildings, equipment and grounds are adequately and routinely maintained. |
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3 |
Scales and liquid metering devices are tested/calibrated upon installation and at least annually thereafter. |
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4 |
Buildings are of suitable construction to minimize access by pests. A written pest control program exists and a record of pest control products used in the facility is maintained. |
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5 |
Buildings provide adequate space and lighting. |
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6 |
Equipment possesses the capability to produce a homogenous product that prevents, eliminates, or reduces identified food/feed safety hazards. A procedure to test the mixer has been developed and includes corrective action to be taken when necessary. Mixers are tested/calibrated upon installation and annually thereafter. |
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7 |
All equipment is of suitable size, design, construction, precision, and accuracy for its intended use. |
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8 |
All equipment is maintained to prevent lubricants and coolants introduction as unapproved additives to finished products. Where contact may be possible food grade products are used. |
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9 |
All equipment is designed, constructed, and maintained to facilitate inspection by the operator and the use of cleanout procedures when required. |
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10 |
Work areas and equipment used for the manufacture and storage of ingredients and feed are kept separate from agrichemicals. |
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11 |
Procedures exist and are implemented to insure all equipment is routinely and properly cleaned to prevent contamination of feed and ingredients. |
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12 |
Adequate procedures are established and used for all equipment in the production and distribution of ingredients and products to avoid contamination of feed and ingredients. |
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13 |
Procedures are established to ensure a biosecure workplace and the firm is following the AFIA "Guide to Biosecurity Awareness" program. |
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1 |
Certification for compliance to 21 CFR 589.2000 is provided by suppliers where appropriate. |
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2 |
Procedures are in place to monitor, qualify, and disqualify suppliers on a scheduled basis and an approved supplier lists exist. |
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3 |
Procedures for conveyance of raw materials to plant are in place to ensure identification of food/feed safety hazards. Suppliers and transportation companies have agreed to cleanout procedure requirements for transportation vehicles. A truck receiving log is maintained documenting cleanout and prior cargo in the truck. |
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4 |
Suppliers are required to place a safety seal on incoming rail cars or trucks. A policy to handle broken bags has been developed and is being followed. |
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1 |
Finished product is properly packaged and labeled for traceability (e.g. production codes), and other label regulatory requirements. |
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2 |
Procedures for product traceability as required by the AFIA Safe Feed/Safe Food Guidelines are documented and implemented and the firm is complying with the FDA's Bioterrorism Act recordkeeping rules. |
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3 |
Bagged ingredients are stored in either original containers or containers with lot numbers for traceability and identification and controlled in mixing areas. Bulk ingredients are controlled in a similar manner, as appropriate. |
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4 |
A sample retention program is defined and implemented. Retained samples are stored in an area away from production that minimizes the potential for contamination. |
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5 |
Daily inventories of drugs are maintained. |
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6 |
Procedures for proper storage to avoid contamination are established for both raw materials, ingredients and finished products. |
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1 |
Product specifications are defined within customer and regulatory requirements. |
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2 |
Procedures for customers' feedback and complaints are in place. |
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