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Questions and Answers
What is the initial change listed in the current release?
What is the initial change listed in the current release?
- Revision of safety procedures
- Listing of members of the Food Defense Team (correct)
- Update of approval signatures
- Addition of section 5.11 Product Tampering
Which section was added in the current release?
Which section was added in the current release?
- Section 6.8 Operational Guidelines
- Section 3.2 Regulatory Compliance
- Section 5.11 Product Tampering (correct)
- Section 4.5 Quality Control
Which role is listed alongside the Food Safety & Regulatory Manager in the approvals section?
Which role is listed alongside the Food Safety & Regulatory Manager in the approvals section?
- Production Manager (correct)
- Safety Officer
- Quality Control Supervisor
- Marketing Director
What does the 'X' indicate in the version change line of the description?
What does the 'X' indicate in the version change line of the description?
What does the acronym 'EFF' likely stand for in the context of revision history?
What does the acronym 'EFF' likely stand for in the context of revision history?
Which date corresponds to the signature of the Director of Regulatory & Quality Assurance?
Which date corresponds to the signature of the Director of Regulatory & Quality Assurance?
Which comment is provided in the approvals section of the document?
Which comment is provided in the approvals section of the document?
Who is the originator of the current release?
Who is the originator of the current release?
What change was made in version 1.1 regarding audit requirements?
What change was made in version 1.1 regarding audit requirements?
Which roles were added to the Responsibility sections in version 1.2?
Which roles were added to the Responsibility sections in version 1.2?
What specific requirements were added for contractors in version 1.2?
What specific requirements were added for contractors in version 1.2?
In which version was the section on Product Tampering added?
In which version was the section on Product Tampering added?
Which update occurred in version 1.1 regarding the structure of section 5?
Which update occurred in version 1.1 regarding the structure of section 5?
What was the focus of the updates made in version 1.2?
What was the focus of the updates made in version 1.2?
Which area saw additional updates from sections 5.6 through 5.10 in version 1.2?
Which area saw additional updates from sections 5.6 through 5.10 in version 1.2?
What is the significance of the date 02-27-20 in the content?
What is the significance of the date 02-27-20 in the content?
What should be primarily provided to all staff, especially new staff?
What should be primarily provided to all staff, especially new staff?
What is essential to perform regularly in order to maintain security?
What is essential to perform regularly in order to maintain security?
What must be established to ensure the identification of staff on the premises?
What must be established to ensure the identification of staff on the premises?
Which of the following actions should be taken regarding staff access to areas of the facility?
Which of the following actions should be taken regarding staff access to areas of the facility?
What should be done in the case of suspected batch tampering?
What should be done in the case of suspected batch tampering?
Which of the following personal items is allowed in non-public areas of the facility?
Which of the following personal items is allowed in non-public areas of the facility?
What is the first action to take if suspected batch tampering is discovered?
What is the first action to take if suspected batch tampering is discovered?
After an incident of contamination, what should be done with surfaces and tools that were affected?
After an incident of contamination, what should be done with surfaces and tools that were affected?
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Study Notes
Food Defense Team
- The document lists members of the Food Defense Team
- The document was initially released on 01-07-20
- The document was updated on 05-24-21 to include the Food Defense Team members and a Product Tampering section
###Â Revision History
- The document was first released on 01-07-20
- The document was updated on 02-27-20 to reflect current document requirements, including the addition of sections on employee lockers, intrusion alarms, and PPE requirements for contractors, vendors, and visitors.
- The document was updated on 04-29-20 to reflect current document requirements, including changes to the purpose, responsibilities, and the addition of food defense areas.
Food Defense Procedures
- Supervision of all staff, cleaning and maintenance staff, contract workers, data entry and computer support staff, and especially new staff is required
- Routine security checks of the premises and critical computer data systems should be conducted
- A system of positive identification and recognition is required to be established
- Access to areas and data systems should be limited to only those necessary for job functions and during appropriate work hours
- The type of personal items allowed in non-public areas of the facility should be restricted
- Personal use medicines are permitted but must be stored away from any product handling or storage areas.
- Staff should be prevented from bringing personal items into preparation or storage areas.
- Unusual or suspicious behavior by staff should be watched for
Product Tampering Procedure
- Any issues related to suspected batch tampering must be brought to the attention of the Quality Team.
- The designated and trained Quality Team Member should handle all actions.
- The area should be secured, and no one should be allowed access without Quality approval.
- All witnesses should be immediately identified, and individuals who have had access to the area, handled the product in question, or were in the immediate or surrounding areas should be identified.
- Anyone potentially affected by the contamination needs to be identified.
- All written material associated with the incident should be secured.
- After investigation by the Regulatory Team, any surfaces and tools that might have come in contact with the product in question should be decontaminated
- The facility should be secured until all areas have been sanitized and the appropriate Regulatory Agency determines the time of contaminant.
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