2.5.15 Equipment Management

2.5.
15 Equipment Management
a) Requirements that need to be adhere:
-The intended use of the equipment must be specified.

-Should conduct equipment design risk assessment
-Hygienic design principles must be specified within purchase specification
- When developing purchase specifications, it's crucial to incorporate both legal requirements
and customer expectations. (for example, compliance with Food Safety Legislation, quality and
performance of the equipment-expected lifespan & durability)
The supplier shall provide evidence of meeting the purchase specification prior to installation.
The supplier should provide documentation such as:
1. Compliance Certificates: Documents confirming that the equipment meets relevant
standards or regulations.
2. Test Reports: Results from tests conducted to verify that the equipment meets the
specified requirements.
3. Technical Specifications: Detailed descriptions of the equipment's features and
functionalities, including how they align with the purchase specifications.
4. Manufacturer's Declaration: A statement from the manufacturer affirming that the
equipment complies with the specified requirements.
5. Installation Instructions: Guidance on how to install the equipment according to the
specified standards.
b) To establish and implement a risk-based change management process for new equipment
and/or changes to existing equipment, the following documents are typically needed:
1. Change Management Policy: A formal document outlining the process and
responsibilities for managing changes.
2. Change Request Form: A standardized form for initiating a change, which includes
details about the proposed change and rationale.
3. Risk Assessment Documentation: A record of the risk assessment conducted to evaluate
potential impacts of the change on safety, quality, and compliance.
4. Impact Analysis: A report detailing the effects of the change on existing operations,
systems, and processes.
5. Implementation Plan: A detailed plan describing how the change will be executed,
including timelines and responsibilities.
6. Training Records: Documentation of any training provided to staff regarding the new
equipment or changes to existing equipment.
7. Approval Documentation: Records showing that all necessary approvals have been
obtained from relevant stakeholders.
8. Post-Implementation Review: A report evaluating the effectiveness of the change after
it has been implemented.
These documents help ensure that changes are systematically managed, thoroughly evaluated,
and properly executed.
Here's an outline for a Standard Operating Procedure (SOP) for equipment management based
on FSSC 22000 requirements. This outline can help ensure that all equipment used in food
safety practices is properly maintained, calibrated, and validated to meet safety standards.
SOP Outline for Equipment Management
1. Purpose
 Define the objective of the SOP, emphasizing the importance of proper equipment
management in ensuring food safety and compliance with FSSC 22000 standards.
2. Scope
 Specify the applicability of the SOP to all equipment used in food production, processing,
and handling within the organization.
3. Definitions
 Provide definitions of key terms (e.g., equipment, maintenance, calibration, validation).
4. Responsibilities
 Outline the roles and responsibilities of personnel involved in equipment management,
including:
o Equipment operators
o Maintenance staff
o Quality assurance team
o Management
5. Equipment Inventory
 Describe the procedure for maintaining an inventory of all equipment, including:
o Identification of equipment
o Location of each piece of equipment
o Specifications and operational manuals
6. Equipment Purchase and Installation
 Detail requirements for equipment selection, acquisition, and installation under food
safety considerations, ensuring compliance with applicable standards.
7. Maintenance Procedures
 Define procedures for regular preventive maintenance, including:
o Schedule of maintenance activities (daily, weekly, monthly)
o Documentation of maintenance performed (checklists, records)
o Responsibility for maintenance tasks
8. Calibration Procedures
 Outline the calibration processes for equipment that requires it, including:
o Frequency of calibration
o Procedures for calibrating measurement instruments
o Documentation of calibration results and actions taken for discrepancies
9. Validation Procedures
 Describe how equipment will be validated for its intended use, ensuring that it complies
with safety and quality standards. Include:
o Protocols for validation
o Documentation required for validation processes
10. Equipment Cleaning and Sanitization
 Detail cleaning and sanitization procedures for equipment to prevent contamination,
including:
o Cleaning schedules
o Cleaning agents and methods used
o Records of cleaning activities
11. Equipment Troubleshooting and Repair
 Provide guidelines on identifying equipment issues, troubleshooting methods, and
procedures for repair, including:
o Reporting procedures for equipment malfunctions
o Temporary measures to maintain food safety during repairs
12. Record Keeping
 Highlight the importance of maintaining proper records related to equipment
management, including:
o Maintenance logs
o Calibration certificates
o Validation documents
o Cleaning and sanitization records
13. Training
 Describe training requirements for staff involved in equipment operation, maintenance,
and management, including:
o Frequency and content of training sessions
o Documentation of training completion
14. Review and Revision
 State the process for reviewing and updating the SOP to ensure it remains current and
compliant with FSSC 22000 standards.
15. References
 List relevant documents, standards, or regulatory requirements that apply to equipment
management.
16. Appendices
 Include any necessary forms, checklists, or additional guidance materials relevant to
equipment management.
This outline provides a comprehensive framework for an SOP focused on equipment

management in compliance with FSSC 22000 requirements. Each section can be expanded with
specific details according to the practices and policies of your organization. If you need more
detailed information on any specific section, just let me know!

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2.5.

a) Requirements that need to be adhere:

-The intended use of the equipment must be specified.

This outline provides a comprehensive framework for an SOP focused on equipment

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