SAFETY AND QUALITY PROCEDURES
Each and every machine has to go through a set of tests in order to be considered client-ready. These tests are checklist-based with very clear criteria. All testing documentation is transparent. No machine “leaves” Tishma Technologies without passing all the tests.
Listed below are some of the examples.
FAT (Factory Acceptance Test)
WHAT DO WE CHECK?
BASIC MACHINE FUNCTION:
Substructure, Access, Cleanability, Dimensions, etc.
SOFTWARE, HARDWARE, AUTOMATION:
Users, Emergency Stops, Guard, Doors, Alarms, Screens, etc.
MACHINE OUTPUT:
Set of different test runs of the machine with clear speed/output criteria depending on a machine.
DOCUMENTATION:
Operator manual, Pneumatic drawing, Layout drawing, Mechanical drawings, Electrical schematics, Software, etc.
QUALIFICATIONS (IQ/OQ)
INSTALLATION QUALIFICATION (IQ)
Evaluating Means Of Accommodating New Equipment And Testing Its Materials.
WE CHECK: Primary Equipment, Ancillary Equipment, Safety Devices, Piping, Utilities, Valve, Trap & Hose, Instruments, Contact Materials and Lubricants, Spare Parts, Controlled Drawings, Maintenance Procedures, etc.
OPERATIONAL QUALIFICATION (OQ)
Verifying that the equipment is achieving all operational requirements.
WE CHECK: Product Level Sensors, Carton Level Sensors, Coupon Level Sensors, Carton Assembly Rates, Carton Configurations, Emergency Stops, Alarm Systems, Guard Door Alarm Systems, Timing Screws, Gripper Sensors, etc.
RISK ASSESSMENT
SAFETY AND SANITATION TEST
This is the process by which the intended use (and reasonably foreseeable misuse) of the machine, the tasks, the hazards, and the level of risk are determined.
We identify the machine or process, collect proper information, gather proper personnel, observe machine in use, identify hazardous areas, identify the risk level and required level of risk reduction.
Machines feature washdown, stainless steel structure with waterproof electrical enclosures, according to NEMA 4x standard.
This means the machine is protected from splashing water and hose-directed water.
TESTING CRITERIA: Must exclude at least 65 GPM of water from a 1- inch nozzle delivered from a distance not less than 10 ft for 5 min.
SPECIFICATIONS
We provide support in drafting and compiling all documentation required to prove
that a development of the machine is compliant with GMP and GAMP5.
User Requirement Specification (URS) provides a list and description of all client requirement to be fulfilled by the machine manufacturer.
Functional Design Specification (FDS) provides the basis of the design of the system and it is used to verify and validate the system during the testing, ensuring all the required functions operate correctly.
The HDS Hardware Design Specification is a document that provides a description of main components, interactions and requirements for connection to utilities and installation.
The SDS Software Design Specification is a document that provides a description of the software, implementation, functions and interface with the users.