P11-0032 MeriCal Food Defense Procedure (PDF)

**CURRENT RELEASE** **Description of Change: Originator:** Mike Majumdar **Reason:** ------------------------------------------------- ---------------------- ------------- **1.** Listed members of the Food Defense Team. **Initial Release** **2. Added section 5.11 P...

**CURRENT RELEASE** **Description of Change: Originator:** Mike Majumdar **Reason:** ------------------------------------------------- ---------------------- ------------- **1.** Listed members of the Food Defense Team. **Initial Release** **2. Added section 5.11 Product Tampering.** **Text Change Only** **Version Change** **X** **Obsolete** **Other** **APPROVALS:** +-----------------+-----------------+-----------------+-----------------+ | **MeriCal-** | **Food Safety & | **Production | **Director of | | | Regulatory | Manager** | Regulatory & | | **UT** | Manager** | | Quality | | | | | Assurance** | | **Authorities:* | | | | | * | | | | +=================+=================+=================+=================+ | **Signatures** | |  | | +-----------------+-----------------+-----------------+-----------------+ | **Dates** | **05-12-21** | **05-21-21** | **05-24-21** | +-----------------+-----------------+-----------------+-----------------+ | **Comments:** | | | | +-----------------+-----------------+-----------------+-----------------+ **REVISION HISTORY:** **REVISION:** **CONTENT:** **EFF. DATE:** --------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ---------------- 1.0 Initial Issue 01-07-20 1.1 Changed title to meet requirements. Added (3) steps to section 5.2.2. Removed sub-sections from 5.3. **Added section 5.2.3. "Employee Lockers" to meet audit requirements.** Added section 5.4. "Intrusion Alarm" from procedure P11-0023. 02-27-20 1.2 Updated the "Purpose" to reflect current document requirements. **Added Director of Food Safety & Regulatory, Site Specific Quality Manager & Site-Specific Plant Managers to the Responsibility sections. Added PPE requirements for contractors, vendors & visitors in 5.2.4. Added Manager/ Supervisor responsibilities in 5.3. Added additional Food Defense areas in sections 5.6 through 5.10.** 04-29-20 1.3 Listed members of the Food Defense Team. Added section 5.11. Product Tampering 05-24-21 **\ 1. PURPOSE:** **2. SCOPE:** **3. DEFINITIONS: N/A** **4. RESPONSIBILITY:** **5. PROCEDURE** **\ ** - **Provide an appropriate level of supervision to all staff, cleaning and maintenance staff, contract workers, data entry and computer support staff, and especially, new staff.** - **Conduct routine security checks of the premises and critical computer data systems for signs of tampering, malicious or criminal actions, or areas that may be vulnerable to such actions.** - **Know who is and who should be on the premises, and where they should be located, for each shift.** - **Establish a system of positive identification and recognition that is appropriate to the nature of the workforce.** - **Limit the access so staff can only enter those areas that are necessary for their job functions and only during appropriate work hours; this also includes access to data operating systems for purchasing, storing and distributing products.** - **Restrict the type of personal items allowed in non-public areas of the facility.** - **Allow only properly labeled personal use medicines into the facility. Personal use medicines are ones that are necessary for the health of an employee and must be stored away from any product handling or storage areas.** - **Prevent staff from bringing personal items into preparation or storage areas.** - **Watch for unusual or suspicious behavior by staff.** **3. Issues related to suspected batch tampering must be brought to the attention of the Quality Team.** - **Have the designated and trained Quality Team Member handle all actions.** - **Secure the area. Do not allow anyone access to the area without Quality approval.** - **Immediately identify all witnesses. Determine who has had access to the area, and identify people who have handled the product in question or were in the immediate or surrounding areas.** - **Determine who might have been affected by the contamination.** - **Secure all written material associated with the incident.** - **After investigation by the Regulatory Team, decontaminate any surfaces and tools that might have come in contact with the product in question.** - **Secure the facility until all areas have been sanitized and the appropriate Regulatory Agency determines the time of contaminant.** **\ ** **\ 6. DOCUMENTATION:** **7. REFERENCES**