Equipment Qualification Checklist - duplicate

Title Page

Site conducted
Document #
Project Start Date
Equipment or Project Name (Include model# in description)
Planned Final Location of Use
- Measuring
- Blending
- Powder Fill
- Encap
- Stick Pack
- Warehouse
- Lab/R&D
- Facility
- Maintenance
- Floater
- Other
Equipment Condition
- New
- Rebuilt
- Modified
- Moved
- Remanufactured
- Existing
Asset # Assigned
Production Launch Target Date
Project Completed Date
Manufacture/Supplier/Vendor
Purchased Date
Document Prepared By
Preparer's Title/Function
Signature
Approved By
Approver's Title/Function
Signature
**IMPORTANT** Please go through each and every section and answer all questions prompted. To navigate, simply scroll through each page until every question has been answered then click "Next". Some answers may be "Yes", "Compliant", "No", "Not Compliant", "N/A" etc. Select the best fitting answer for each question and add any additional comments at the very end of the sections in the "Comments and Concerns" fields. For questions prompting for signatures, please press the small blue icon to the right of the answer text box.

DQ (Design Qualification)

Objective

Scope

This document is applicable for the equipment & requirements listed on the title page.

Responsibility

The manufacture/supplier/vendor is responsible for ensuring that the design will satisfy the URS & FRS. Review and approval will be conducted by both parties.

Requirements

Attach User Requirement Specifications (URS)
Attach Functional Requirement Specifications (FRS)

Sanitary

Cleanable to a Microbiological Level

Food equipment must be constructed to ensure effective and efficient cleaning over the life of the equipment. The equipment should be designed as to prevent bacterial ingress, survival, growth and reproduction on both product and non-product contact surfaces of the equipment
Equipment is designed to be constructed & maintained in a cleanable condition to prevent the ingress, survival & multiplication of microorganisms (measured post installation)
Surfaces are considered acceptably clean when a 10cm2 area is swabbed with a supersnap swab, tested using the Ensure luminometer, meets the following ATP requirements: <17 RLU for cleans taking place following an Allergen run and/or a Non-Allergen production run. (measured post installation)
All surfaces are accessible for mechanical cleaning & treatment to prevent biofilms formation (measured post installation)
Surfaces are clean visually and to the touch, & pass preop inspections using sight, touch & smell (measured post installation)
When requested, data are available to demonstrate that soiled equipment is cleanable (as defined above) by an individual using the cleaning protocol provided by the equipment supplier (measured post-installation)

Made of Compatible Materials

Construction materials used for equipment must be completely compatible with the product, environment, cleaning and sanitizing chemicals and the methods of cleaning and sanitation
Materials used in construction are compatible with the product, the environmental conditions they will be exposed to, as well as the cleaning methods & chemicals
Product Contact Surfaces must be made with materials which are corrosion resistant, nontoxic, and nonabsorbent as per NSF/ANSI/3A 141591
In general, Stainless Steel shall be AISI 300 series or better
Composites & plastics remain intact without changes in shape, structure & function thru cleaning & sanitation protocols
Plated, painted & coated surfaces are not used for food contact surfaces or for surfaces above the product zone areas
Cloth-back belts are not used
Coatings and plating must remain intact
Materials not used include wood, enamelware, glass, uncoated aluminum , uncoated anodized aluminum, etc. per NSF/ANSI/3A 141591
Metals are compatible with one another
Seals and O'rings will be designed to minimize product contact
Pneumatic systems do not exhaust in or near the product contact surfaces. Cylinders, supply lines and return lines are sealed and do not allow the ingress or egress of soils

Accessible for Inspection, Maintenance, Cleaning & Sanitation

All parts of the equipment shall be readily accessible for inspection, maintenance, cleaning and sanitation
For product zone components with inaccessible surfaces (i.e., do not allow penetration of detergent), equipment disassembly is as easy as possible and preferably tool free
All surfaces in the product zone readily accessible for cleaning and inspection
Where access or disassembly is not possible, the entire assembled unit is cleaned by CIP (preferred) or COP methods. The design enables circulation of detergent to ensure an effective combination of time, temperature, chemical strength and mechanical action effectively cleans the assembly. (Verify post installation)
Parts needing cleaning remain attached or are hung on the equipment for easy cleaning and to prevent damage or loss. Separate parts baskets and/or movement to a cleaning room can be used as an alternative
Machinery and chain guards drain away from product zones and are easily removed. There are work instructions from the supplier for accessing and cleaning on a periodic basis, if applicable
Product catch pans or drip pans are easily removable for cleanup so that they are not lost or separated from the equipment and cleaned on a periodic basis
All belting is easily removable or the belt tension is removed easily to the surfaces underneath can be cleaned
All surfaces in nonproduct zones shall be readily accessible for cleaning and inspection
Installations will maintain an 18” floor clearance for any product contact areas or conveyor travel paths. Equipment design provides 12” of clearance to the floor
All product air, vacuum and transfer hoses, and their assemblies, on the equipment are easily removable for soaking and sanitizing
All product air, vacuum and transfer hoses are transparent or semitransparent and meet product contact surface guidelines

No liquid Collection

Equipment should be self-draining to assure that liquid, which can harbor or promote the growth of bacteria, does not accumulate, pool or condense on the equipment
All surfaces and guards should be designed to eliminate water pooling and be self-draining
Framework used for horizontal members is rounded. If square or rectangular basis is used the surfaces are angled so water will drain and not pool
All open surface areas are made of sufficient strength to prevent warpage or denting and subsequent pooling of water during the life cycle of the equipment
Moisture does not drip, drain or draw into product zone areas
Belt tension is adequate throughout operations to prevent water pooling on belts
Materials used shall be nonabsorbent

Minimize or Eliminate Hollow Areas

Hollow areas of equipment such as frames and rollers must be eliminated wherever possible or permanently sealed. Bolts, studs, mounting plates, brackets, junction boxes, nameplates, end caps, sleeves etc should be locked or sealed in position. Hollow areas are not acceptable at or above the contact zone
All rotating members, such as drive sprockets or belt pulleys, are to be solid or fully sealed with continuous welds for the life of the equipment. Sprockets adjacent to the food contact surface are assumed to be solid, not made to be solid equivalent by continuous welding
Leg adjustments should be external and cleanable
Name plates and tags are minimized and should not be place above or adjacent to the contact surfaces.
All inaccessible parts outside the product contact zone prevent entry of foreign materials

No Niches

Equipment parts should be free of niches such as pits, cracks, corrosion, recesses, open seams, gaps, lap seams, protruding ledges, inside threads, bolt rivets and dead ends
Internal corners and angles shall have a smooth and continuous radius of at least 1/8 inch (angles of less than 135°)
There are no lap joints
Hermetically sealed spacers are used to allow for space between two adjoining pieces to permit mechanical action during cleaning. For ease of cleaning, the space should not be less than .5 inch
Caulking, sealants or lubrication is not used in or above the product zone unless it is food grade
All joints and welds are flush and free of pits, cracks and corrosion
All welds are continuous, smooth and polished
Sleeved assemblies (e.g., bushings, sprockets, bearings) are no longer than 11/2 inches or are disassembled for cleaning
Press and shrink fits are not used
If fasteners are necessary in or above the product zone, they do not have exposed threads and have a positive locking method to prevent falling or vibrating off

Operational Performance

During normal operations, the equipment must perform so it does not contribute to unsanitary conditions or the harborage and growth of bacteria
Buttons, knobs, switches, gauges, displays etc, on control panels are easily cleaned and sanitized during operations in order to not create a microbial harborage
All compressed air used for blowing on the product or contact surfaces is filtered to a minimum of a 0.3 micron level and dried to prevent the formation of moisture in the piping system. Filtration is located as close to the product contact zone as possible
No bearings are present in or above the product contact zone areas. If they are, they must contain only food grade lubricant and are enclosed in a sealed housing
Separation between product contact and nonproduct contact areas prevents cross contamination during operations
All surfaces directly connected to the product contact zone areas are designed as if they were product contact zone areas
Product contact surfaces are made to prevent buildup of product residue during operations
Shafts passing through a product zone shall have an air gap to prevent product contamination

Hygienic Design of Electrical Enclosures

Maintenance enclosures and human machine interfaces such as push buttons, valve handles, switches and touchscreens, must be designed for easy cleaning/sanitizing during operations in order to not create a microbial harborage, and to ensure that product residue or water does not penetrate or accumulate in and on the enclosure or interface. Also, physical design of the enclosures should be sloped or pitched to avoid use as a storage area or residue accumulation point
Electrical controls are not located over open product zones.
Control and junction boxes are fastened to the frame in a manner consistent with the sanitary design principles
Utility supply lines, pipes and wiring are separated enough with clearance to prevent catch points and allow for cleaning. Bundling of wires should not interfere with cleaning
Utility lines are 12” off of the floor and cleanable
Conduit and supply lines are not routed above product contact areas
Maintenance enclosures in direct wash down areas must be able to be exposed to water and chemicals used in cleaning and sanitation. Cleanable to a microbial level may apply to enclosures that are in close proximity to the product zone. Securing with a plastic bag is not acceptable. Should be NEMA 4/IP65 minimum rated

Hygienic Compatibility with Other Systems

Equipment that requires additional sub systems, such as exhaust, drainage, or automated cleaning systems, does not create sanitary design risk because of the soil load, operational conditions, or standard sanitation operating procedures. Consideration is given to exhaust duct design, the ability for drain lines to remove liquid effectively, and the effectiveness of CIP systems for the process. This means while completing the checklist, take a look at the equipment and its supporting systems together as a whole versus individually and evaluate how they will likely function as a system
Exhaust systems have welded seams with adequate access for cleaning and inspection
In sections of ductwork that are not easily cleaned through access opening, CIP systems are designed, installed and validated to confirm cleanliness
Vertical duct sections have a drain (e.g., to the floor) to prevent drainage from going back into the equipment
Separate exhausts on equipment are supplied for product zones and non product zones.
Equipment drainage is designed to assure no backups of drainage lines result under normal operations
Compressed air outlets and outlets that exhaust from pneumatic cylinders do not exhaust onto or adjacent to product contact surfaces. Exhaust return lines should be utilized.
Fan cooled motors do not blow air onto or in the direction of product contact surfaces
Electrical power supplies should be enclosed in conduit, sealtight, or cord to prevent ingress of materials and which can be easily cleaned/sanitized

Validated Cleaning and Sanitizing Protocols

Procedure for cleaning and sanitation must be clearly written, designed and proven effective and efficient. Chemicals recommended for cleaning and sanitation must be compatible with the equipment and the manufacturing environment
Cleaning and sanitizing are considered in the design process
Cleaning and sanitation protocols have been developed by the manufacturer, validated, and provided in a training manual that is easily read and understood by cleaning and sanitation employees
Equipment design and materials are capable of withstanding standard cleanup procedures and MSDS for the cleaning and sanitizing chemicals have been reviewed to assure compatibility. Special/deep cleaning should be scheduled based on indicators such as mean time failure analysis
All equipment components including belts and product contact components should be able to withstand heating to 160°F for up to 5 minutes. Procedures to protect sensitive components should be included in manufacturer’s procedures and followed

Electro-Mechanical

Electrical

All electrical conductors are installed, colored, marked/designated in accordance with NFPA 79 (i.e.: conduit, seal tight, cable tray, H.D. flexible cord w/strain relief.)
Electrical system is appropriate for environment (i.e. class II, div II, IP65/NEMA 4)
All electrical components used in Class II, Division II, Group G areas are intrinsically safe
Highest voltage present in cabinets is marked on exterior, and designate equipment to which it is connected
All power connections > 50 volts inside cabinets shall be touchproof
All panel doors, with electrical components > 50 volts are bonded
All safety devices are control reliable/fail safe (light curtains, gate plugs, PLS's, etc.)
Safety Control circuits meet ANSI/RIA/ISO standards
All switches or function control knobs are appropriately marked
Two-hand cycle start or controls are anti-repeat/tie down
Equipment status lights (if equipped) show status of: Normal condition, Fault, Trouble/warning
Load lights (if equipped) show status of: OK, Parts Out of Position; E-Stop/fault
Paint is scraped off beneath all equipment ground connections
All unused external openings in electrical cabinets are filled
Electrical control panels have at least 3ft in front of panel door and door can open at least 90 degrees. If rear access is needed, the same guidelines apply
If more than one power source is used to supply energy to an electrical panel a sign on the door indicates same
What type of control system is used? (PLC, HMI, Safety -- Brand, Model, Software)

Guarding/Marking

All operator controls must be labeled in English
Main electrical control panel nameplate has information specified by NFPA 79
All machine guarding hazards are protected by adequate controls
All high voltage enclosures and terminal boxes have the IEC 60417-5036 warning label (lightning bolt symbol) on them
Presence sensing devices will not allow a person to pass through and access the hazard(s)
Safety fence prevents someone from accessing hazard, contains any hazards, and does not create a hazard
If muting is required to allow vehicle or parts travel, additional presence sensing and/or physical guards shall be used to prevent personnel access during the muting
Cabinets, panels, racks used as perimeter guarding prevents someone from accessing hazard, contains any hazards, and does not create a hazard
Interlocked gates/doors put equipment into Estop mode. Interlocks cannot be easily bypassed
Interlocks and gate/door trapped key devices have 2 sets of contacts
Reset/restart after initiation of a safety device requires two specific steps outside safeguarded space
Pulleys, sprockets, sheaves, cables, capstans, drums, and gears must be completely covered. Leading side of pulleys, sprockets, and gears must be below cover plates
No human body potential pinch points exist at less than 20 inches without proper guarding; relevant areas should be marked with warning label
All chemical lines/piping labeled to contents and directional flow
Painting shall be in addition to, not in lieu of, guards or other protection devices
Where protective devices are required, the deceleration/stopping of the machinery has to be taken into account and stopped before person can access hazard. A time delayed device is present to assure hazard stops before access is granted
Areas under lift tables must have baffles or other means to prevent access
Pneumatic controls for manipulators/clamps cannot be accessible from outside the safeguarded area
Equipment corners and edges shall be rounded and/or covered/padded to prevent injury
Leveling feet need to be provided to allow for adjustment to unlevel/pitched floors
Spare parts identified and listed based on life cycle (quick-wear) and importance (custom/specialty, long lead-time)

Conveyors/Product Conveying

Conveyor speeds must be specified to operate @ +/-10% of the target application range
Conveyors have potential pinch points (<20 inches) protected
Conveyors have Estop buttons available (or equivalent)
A continuous automated linked 100 ft or longer has adequate crossovers/passthrough. Crossovers are free of pinchpoints and painted yellow
Any product contact surfaces must follow the same sanitary guidelines as the primary equipment

Safety

Control of Hazardous Energy – Lockout/Tagout (LOTO)

All energy sources are capable of zero energy LOTO. All energy isolation points need to be no higher than 7 feet and near the point of operation while being easily accessible.
All potentially hazardous energy disconnects/sources shall be lockable using an standard lock-out device that supports a safety lock or hasp.
Equipment has automatically dissipate stored energy or when not possible, bleed off valve are available. Additionally blocking devices shall be available for gravitational energy.
The main circuit breaker/disconnect is mechanically interlocked with the control panel door and is lockable, or a tool/key is required to open the door and has a warning sign to "Disconnect Power Before Entering"
Maintenance circuits that are tapped from the "line" side of the main circuit breaker are lockout/tagout capable
All related or interactive equipment in a system is deactivated when any individual piece of equipment in that system is deactivated under Lockout/Tagout
LOTO Placards are posted in appropriate locations and power sources identified, including gate switches

Safety Devices

Where there are conflicts, requirements that result in a safer condition will prevail
Where operators must initiate a cycle start, presence sensing devices shall be used to protect operator
Presence sensing devices must be installed to prevent operator access to hazardous motion
All presence sending devices shall be of failsafe design
Safety mats should be avoided unless absolutely necessary. Backup mats shall be available in c case primary are damaged
Safety mats are installed at a distance of 48 from hazard, secured to floor, and has edging
Foot pedals have protective covers. They shall not be used for clamping. Can be used for unclamping

Emergency Stops (EStops)

All Estops are Category 0 and immediately stop all hazardous motion. Other categories may be considered based off equipment and hazards
Estops are red mushroom type with yellow background
Estop buttons do not have guards or covers that could potentially interfere with the Estop from being engages
Estop buttons are not used as a point of energy control for Lockout/Tagout
Required e-stop(s) are visible, operational, and ergonomically placed
Estop circuits and Safety Stop circuits are separate circuits. (i.e.: Safety Gate Plugs/Interlocks and Emergency stop circuits.)
Estops shall stop all moving components. Estops located at the junction of two safety zones shall stop both zones

Approval

Any additional comments and/ or concern please type here
Please attached photos for references of comments and concerns
Authorized Supplier/Manufacture Representative Name/Title
Signature
Name of Armada Engineering Representative
Signature
Name of Armada Safety Representative
Signature
Name of Armada Quality Representative
Signature
Name of Armada Project Manger (if assigned)
Signature
Name of Armada Executive
Signature

FAT (Factory Acceptance Test)

Objective

This FAT is a verification that the equipment design meets the User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) within this document. These activities may take pace at the manufacture's site or be included as part of the SAT at Armada's site, depending on the whether the equipment is 'off the shelf' or it's complexity requires both activities.

Scope

This document is applicable for the equipment & requirements listed on the title page.

Responsibility

Armada Nutrition will provide the URS & FRS. Representatives of the manufacture/supplier/vendor and/or Armada Nutrition will operate the equipment, perform the qualification and record the data/information. Review and approval will be conducted by both parties.

Requirements

Pre-FAT -- Factory Acceptance Test Checklist

Will this FAT be conducted at the supplier/manufacture?
The FAT will occur at Armada in combination with the SAT. Many of the topics in this section will be answered N/A. Refer to the SAT Section to complete the verification & validation.
Are the URS & FRS fully understood and being prepared to be satisfied during this FAT?
What is outstanding and needing clarification?
Who is responsible?
What is the target completion date?
Was it completed?
Has the proper amount and types of materials been made available to complete the testing of all the required products?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Are all the tools available to perform the related functions and training during this FAT?
List the requirements
Who is responsible?
Can the FAT continue?
Is the proper measuring and/or test equipment available to verify/validate the equipment/process function, repeatability, quality, etc to satisfy Armada's requirements?
List the requirements
Who is responsible?
Can the FAT continue?
Attach supporting documentation

Factory Acceptance Test Documentation

The following items below should be completed prior to or during the FAT. Incomplete items should be completed prior to shipment. Items that can't be completed before shipment must have defined due dates when they will be completed, and agreed on during the FAT by both parties in order to be scored as part of a successful FAT. All documentation must be in English unless otherwise required.
What are the URS & FRS that need satisfied? Attach document or list specific test criteria, ranges and acceptable variations
List the criteria
Certificates of Compliance (included in manual/documentation package)
Need to be included prior to shipment
Instruments Calibration/Certification (included in manual/documentation package)
Need to be included prior to shipment
Standard Work/Operating Procedures (included in manual/documentation package)
Need to be included prior to shipment
Sanitation & Cleaning Procedures (included in manual/documentation package)
Need to be included prior to shipment
Set-up & Changeover Procedures (included in manual/documentation package)
Need to be included prior to shipment
Standard Maintenance Procedures, PM Frequencies (included in manual/documentation package)
Need to be included prior to shipment
Installation, Maintenance/Troubleshooting and User's Manuals (included in manual/documentation package)
Need to be included prior to shipment
Equipment/Components/Devices Data Sheets (included in manual/documentation package)
Need to be included prior to shipment
Recommended Spare Parts List (included in manual/documentation package)
Need to be included prior to shipment
Easy-to-use training materials (included in manual/documentation package)
Need to be included prior to shipment
As-built Technical Drawings: electrical, mechanical, pneumatic, process schemes, parts etc. (included in manual/documentation package)
Need to be included prior to shipment
Materials certificates and data sheets for product contact surfaces (included in manual/documentation package)
Need to be included prior to shipment

Factory Acceptance Test Personnel

Who will be present/responsible during the test to collect and analyze the data to determine if the target criteria has been met?
Will training of Armada personnel accompany the testing?
Will training take place at Armada during the SAT?
Attach on-site training documentation (attendance list, photos/video)

Factory Acceptance Test Site Preparation (Supplier/Manufacture)

The supplier/manufacture must prepare their facility or applicable testing area to satisfy the following criteria prior to commencing the final testing where Armada employees will be present on-site. Record of this checklist should be completed and provided to Armada prior to employee arrival.

Safety Inspection

Select the following items below as "Yes", "No" or "N/A". Those listed items answered "No" should have a corrective action defined. If no corrective action will be taken/prepared for those items, then this indicates that the issue will present during the FAT.
Are equipment guard doors accessible and easy to use?
Corrective action
Are equipment emergency stop buttons configured and in the proper locations to permit easy activation during an emergency?
Corrective action
Are fire alarms in the facility functioning correctly?
Corrective action
Are fire extinguishers in the facility in place and clearly marked?
Corrective action
Are/will FAT personnel be aware of the location of the first aid cabinet?
Corrective action
Are SDS available for any hazardous materials being used?
Corrective action
Are machinery nameplates visible?
Corrective action

Hazard Identification

Select the following items below as "Yes", "No" or "N/A". Those listed items answered "Yes'" should have a corrective action defined. If no corrective action will be taken/prepared for those items, then this indicates that the hazard will present during the FAT.
NOISE: Consider the need for hearing protection in the test area. Will the test create higher noise levels?
Corrective action
FIRE / IGNITION SOURCES: Is hot work is being conducted in the test area? Consider containment / testing requirements.
Corrective action
HAZARDOUS SUBSTANCES: Will the test involve contact with any Hazardous Substances? Refer to MSDS and consider specialized PPE / precautions.
Corrective action
ASBESTOS: Consider if FAT personnel may be exposed to asbestos during this test?
Corrective action
SLIP & TRIP HAZARDS: Consider if any slip / trip hazards are present at the test site. Will the equipment to be tested form a trip hazard? (power cords, other utility supplies)
Corrective action
FALLING OBJECTS: Will the factory acceptance test be performed above where others may pass? Will the FAT personnel be testing the equipment below others?
Corrective action
LIFTING: Does the FAT involves crane lifts?
Corrective action
TESTING AT HEIGHTS: Are FAT personnel are working at heights during this test?
Corrective action
TESTING OUTDOORS: Are there any ambient conditions/associated hazards regarding exposure to heat/cold.
Corrective action
ENVIRONMENTAL IMPACTS: Is there potential to release pollutants to drains, marine environment, waterways, ground, atmosphere? Is the vibration/noise/emission beyond the project perimeter and generation of dust or disposal of hazardous waste?
Corrective action
GUARDING: Will any safety guards/devices be bypassed in order to conduct the testing or on-site training?
Corrective action

Ergonomic Assessment

Select the following items below as "Yes", "No" or "N/A". Those listed items answered "No" should have a corrective action defined. If no corrective action will be taken/prepared for those items, then this indicates that the issue will present during the FAT
MANUAL HANDLING: Consider if the FAT contains any Manual Handling Risks.
Are all instruments or materials as close as possible to the test area?
Corrective action
Are there carts, dollies, or other aids readily available for moving instruments or materials?
Corrective action
Is the test area set up properly to ensure a smooth process flow with minimal material handling?
Corrective action
Is the FAT personnel trained on safe lifting techniques, uses, and carrying devices?
Corrective action
Will materials/component be auto-fed via conveyor or other transfer device?
Corrective action

FAT -- Factory Acceptance Test Protocol

The following items below should be observed, reviewed and confirmed according to the URS during the FAT. Failed items will need to be discussed and corrective action completed prior to shipment. Items that can't be completed before shipment must have defined due dates when they will be completed, and agreed on during the FAT by both parties, in order to be scored as part of a successful FAT.
Safety Check
Corrective action
Completion Due Date
Regulatory/Sanitary Design/Components
Corrective action
Completion Due Date
Electrical panels/enclosures NEMA4/IP65
Corrective action
Completion Due Date
User Interface
Corrective action
Completion Due Date
Has the access levels of the operational software been set up accordingly with passwords where applicable? (operator, tech, admin, etc)
Corrective action
Completion Due Date
Control System/PLC/HMI
Corrective action
Completion Due Date
Trigger/Interlock/Handshake Signals
Corrective action
Completion Due Date
In-line/Tracking/Feeding Systems
Corrective action
Completion Due Date
Opted in add-on part(s) & options present (swivel casters, low level sensors, alarms, changeover tools)
Corrective action
Completion Due Date
Setup Process
Corrective action
Completion Due Date
Startup Process
Corrective action
Completion Due Date
Change-Over Process
Corrective action
Completion Due Date
Shutdown Process
Corrective action
Completion Due Date
Sanitation/Cleaning Process
Corrective action
Completion Due Date
Maintenance, Troubleshooting, Repair, Parts
Corrective action
Completion Due Date
Validation of drawings/diagrams/schematics (electrical, ladder logic, pneumatic, CAD, parts, etc)
Corrective action
Completion Due Date
All system parts that need repair or preventative maintenance are accessible:
Ergonomics - Ease of Use
Corrective action
Completion Due Date
Utility supplies and connections; type and amount (electric, air, water, steam, heating, cooling, etc)
Corrective action
Completion Due Date
Waste streams/by-products and connections; type and amount (noise, radiation, duct collection, steam, air, light/laser, wastewater, etc)
Corrective action
Completion Due Date
Certified/Expected Cycle Life (if applicable)
Corrective action
Completion Due Date

FAT -- Performance Test

In addition to the completion of the preceding items, a performance cPk of > 1.00 for each product/condition test (min 100 data points) is required in order for the FAT to be qualified successful. This should be observed and the data recorded during the FAT by on-site personnel. Failed items will need to be discussed and corrective action completed prior to shipment. Items that can't be completed before shipment must have defined due dates when they will be completed, and agreed on during the FAT by both parties, in order to be scored as part of a successful FAT. If Armada personnel are not on site, then the data must be recorded by the supplier/manufacture and sent to Armada to calculate the results. A minimum 10 second video of each product/condition test must accompany the data.
Sensors detection for all products
List the failures & corrective action
Completion Due Date
Adjustment/set-up range is satisfactory for entire product portfolio specified in URS
List the failures & corrective action
Completion Due Date
No scuffing, scratching, deformation, damage, change, etc. on/to the product being tested was observed for the entire product portfolio specified in the URS
List the failures & corrective action
Completion Due Date
Testing and data collection was completed for the entire product portfolio specified in the URS
List the failures & corrective action
Completion Due Date
Delivery of the performed FAT Protocol, test/performance data and documentation package
Corrective action
Completion Due Date

Post-FAT -- Factory Acceptance Test Follow-up Items

Have all the tools and/or test equipment that were needed to perform the related functions and training during this FAT been discussed (provided or listed to order) so that they will be available for the SAT/training at Armada's site?
List the requirements
Who is responsible?
List tools/equipment needed to order if required
Who will be responsible?
The following is a list of additional or unexpected issues/items that came up during the FAT that still need answers/corrective actions defined
Item #1
Completion Date
Item #2
Completion Date
Item #3
Completion Date
Item #4
Completion Date
Item #5
Completion Date

Approval

This equipment has been manufactured, tested and approved according to the specifications of Armada Nutrition. After all signatures are recorded, a report will be published and provide to both parties.
This equipment is now ready to be prepared and scheduled for delivery to Armada's site.
Name of Supplier/Manufacture Representative/Project Manager
Signature
Name of Armada Engineering Representative
Signature
Name of Armada Operations Representative
Signature
Name of Armada Quality Representative
Signature
Name of Armada Safety Representative
Signature
Name of Armada Project Manger (if assigned)
Signature
Name of Armada Executive
Signature

Equipment Packing, Transport, Receipt, Acceptance

Objective

To ensure that the qualified equipment is packaged and shipped to Armada, & that is has arrived complete and undamaged.

Scope

This document is applicable for the equipment & requirements listed on the title page.

Responsibility

The manufacture/supplier/vendor will package equipment and components and arrange shipment. (Armada Nutrition may decide to arrange shipment if applicable). Armada will receive the goods and conduct the acceptance inspection.

Requirement

Is the supplier/manufacture responsible for the crating/packing of the equipment after the FAT? (per quotation)
Who is responsible?
Is the supplier/manufacture responsible for the transportation of the equipment from their factory/supplier to Armada? (per quotation)
Who is responsible?
Has it been arranged; method and delivery date determined?
Who is the carrier/method?
When is is scheduled for delivery?
Who is responsible for arranging it?
When will it be scheduled for delivery?
Has the equipment arrived within the required due date?
Why/What is the delay?
When will it arrive?
How will this affect the project timeline?
Are all items packed for transit removed from the corresponding boxes, crates, etc? Everything accounted for as printed on the packing slips?
List the missing items
Attach supporting documentation (note on packing slip, take photo)
Has a visual inspection of the arriving items identified any physical damage of components and/or cases?
List the damaged items
Attach supporting documentation (photo)
Have all spare parts been been transferred to Maint and coordinated for location assignment and entry into the CMMS?
List the missing items
Attach supporting documentation (note on packing slip, take photo)

Approval

Any additional comments and/ or concern please type here
Please attached photos for references of comments and concerns
Inspector Name/Title
Signature

IQ (Installation Qualification)

Objective

This IQ establishes the documented evidence that the equipment is properly installed and configured in the selected environment and for the intended application according to Armada's requirements. This section may need to be completed twice if the equipment/activities will take place in two different locations (temporary training area & final installation location).

Scope

This document is applicable for the equipment & requirements listed on the title page.

Responsibility

Engineering and/or Maintenance (internal or external) will perform the equipment installation, connections & set-up in the required area(s), qualification and record the information. Operations, Quality & Safety will verify the installation meets their requirements. Any deviations/changes needed can be listed in the "Any additional comments and/or concern" field at the end of this IQ document.

Requirements

Documentation & Preparation

Identify the location/area in which the equipment/process will be installed. (training area or final location)
Please insert a description
Attach supporting documentation (photo/short video)
Insert a brief description of the operational function of the equipment/process being installed.
Please insert a description
Attach supporting documentation (photo/short video)
Insert a brief description of what is the process requirement(s) of the validated product.
Please insert a description
Attach supporting documentation (photo/short video)
Do any facility constructions/modifications/installations need to be completed prior to the equipment installation?
List the requirements
Who is responsible?
What is the target completion date?
Has it been completed?
Attach supporting documentation
Has the area been isolated to prevent contamination to adjacent areas, and clearly marked as a construction zone with authorized personnel entry only?
What is outstanding?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
If outsourced, has the contractor company and individual workers completed the contractor orientation/safety training prior to beginning work?
What is outstanding?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Have all facility constructions/modifications/installations been completed and approved by relevant authorities where required?
What is outstanding?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Have all required legislated obligations been completed prior to equipment installation where required?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
List the requirements
Attach supporting documentation
Are the ambient conditions of the equipment final location met according to the equipment/process specifications (cGMP, lighting, temp, humidity, etc)? Are they being monitored if required?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Will the equipment/process create emissions or any other by-product which may impact the environment or personnel?
Which emission/by-product?
Have environmental/safety controls been installed to prevent emissions from creating a hazard?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
List the requirements
Attach supporting documentation (photo, compliance document)
Is a HAZOP/risk assessment required for this equipment? (Do it for high risk/complex equipment)
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Has a baseline health surveillance been performed where required?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Are the health surveillance and testing programs in place?
Attach supporting documentation
Are Specific Emergency Plans and relevant procedures/equipment in place where required?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Has the Pressure Vessel Compliance Checklist been completed where required?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (Pressure Vessel Compliance Checklist)
Has a Standard Operating Procedure (SOP) been completed for the equipment?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Has a Standard Operating Condition (SOC) been completed for the equipment?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Has a Sanitation Checklist/Cleaning Procedure (SOP) been completed/updated for the equipment and surrounding affected areas?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Are the serial numbers, model numbers of all applicable machine components identifiable via nameplate/label for entry as asset information in the CMMS?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Is there an English language version of the instruction/operating/maintenance manual available? All documentation required will be assembled as a manual binder and located in Maintenance for reference?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Is there an English language version of the software available? All documentation required backed up and archived for future reference? Validation of CAD, other drawings and softwares; copies backed-up and archived?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation
Any additional comments and/ or concern please type here
Please attached photos for references of comments and concerns
Inspector Name/Title
Signature

Safety -- Facility General Guidelines Inspection

Marking

All chemical lines/piping labeled to contents and directional flow
All fixed bump or trip (except floor) hazards shall be effectively identified and colored yellow or yellow/black striped. Floor mounted trip hazards shall be yellow (i.e. rack locator angle iron). All moving bump or trip hazards shall be identified orange. All pinch, cut or crush hazards shall be identified by red. Signs shall also be required where the source and presence of the hazards is not clearly apparent to untrained personnel
All holes > 6 inches (150 mm) wide (cover off) in floor or mezzanine shall be painted red one foot (305 mm) around the entire opening, and with four inch (0.102 m) wide yellow and black, diagonal stripes, two feet (610 mm) outside the red paint. All holes must have covers that are fitted to the hole (covers cannot slide when in place)
A minimum of 20 inches (500 mm) shall be provided between fixed structures and moving objects/conveyors, at both floor and mezzanine levels. The entire moving path underneath transfer/lifting stations shall be painted red
Maintenance access clearance must be planned to provide 1meter (3.3 ft) access for maintenance purposes
Minimum 3 ft of clearance provided for fire equipment, exits, and electrical panels
Designated pedestrian aisles shall be marked around the installation area and have/lead traffic accordingly throughout the facility

Guarding

Per OSHA, all platforms higher than 4 ft (1200 mm) shall be equipped with 42 inch (1067 mm) tall sturdy hand railing that includes a mid rail and toe plate
All suspended fixed obstacles are above 7 ft. If this is not feasible the hazard shall be padded and marked with yellow and black stripes
If there is an overhead obstruction with little to no risk then the required clearance is 7 ft (2133 mm)
No process equipment into aisle ways
As much as possible, trip hazards due to hoses, cables and pipes shall be eliminated by design of the station
Protection (guard railing/posts) must be installed for every control panel, computer stations, columns, etc. that are exposed to logistic
All light fixtures hanging lower than 7 ft (2133 mm) above the walking surface shall be protected against impact to the bulbs. If lights are lower than 7 ft then bulb must enclosed with protection to prevent breakage
Floor penetrations and openings must be guarded with a kick plate and standard railing

Flooring

The floors shall not have uneven areas, holes, trip hazards, or hazardous slopes The flooring must be secured against shifting, must bear sufficient load, and prevent slipping. Areas in the flooring where there is a general height difference of more than 4 mm (0.16 in) are considered trip hazards
The ground is level or pitched no more than standard equipment leveling feet will accommodate?
Where there is change in floor height in a work area it must be identified with a marked warning ramp or equivalent to prevent falling
In areas where steel grates are used for flooring there shall be a system in place where grating can be cleaned without removal of grates. If grates require removal then the lifting must comply with NIOSH Recommended Weight Limit (RWL)
A standard dimension grate shall be used that can be interchangeable. Custom sized grates shall be avoided
Grating grid size should be as small as possible as appropriate for application. Grid size of 10 x 20 mm (0.4 x 0.8 in) is the optimal size. Shifting the grates within the frames/mounting must be limited to less than +/ 5 mm (0.2 in) side to side or front to back motion. No gap in the flooring should be greater than 15 mm (0.5 in)
Grating in areas where there is increased slip hazards shall have toothed metal edges to prevent slipping
Antifatigue flooring in all operator workstations. The antifatigue flooring shall be designed into the layout of the station. Where antifatigue mats are used they shall not create a tripping hazard
Cable ducts, conduit, piping and other permanent installations in the walk path are trip hazards. Covers must be placed over these points to reduce the risk of tripping and must be painted yellow
Floor openings above 4 feet must be equipped with proper guardrails, toe boards, or fall protection with approved and rated anchor point
If equipment lifts or process equipment is requested to be mounted to the building structure, written approval must be obtained from the engineering group/upper management

PPE/Environment

Vendor/manufacturer has outlined PPE recommendations based off potential hazards and chemical use
All supplied air is Grade D with unique air nozzle fittings. Equipped with continuous monitoring for CO and O2, at a minimum
All potential health hazards produced are identified and rectified by manufacture. Provided IH testing lab results to assure PEL' and TLV's are not exceeded
Equipment noise level is below 80 dBa. If multiple pieces of equipment are present, noise levels are below 83 dBa. Else required hearing PPE shall be posted.
To reduce accidental slips/falls and to promote good housekeeping practices, objects should be kept off the floor. Stationary fans, tool stands, DC electric tools, etc. must be elevated off the floor
In the event of special risks, additional protection shall be provided. Including: enabling devices, anchor points for fall protection, etc

Ergonomics

All lifting tasks must comply with the NIOSH Recommended Weight Limit
Lifting tasks that exceed guidelines have been evaluated with the NIOSH RWL analysis tool
Workstations are to be designed based on ergonomic best practices
The ergonomics design criteria for hand held fixtures are met
Overhead work shall be minimized as much as possible
Deviations from the ergonomics requirements must be approved by the Safety Department

Emergency Equipment

Emergency showers and eye washes shall be provided if there is a risk of splashing caustic, other corrosive material. If an emergency shower or eye wash is mounted there must be a plumbed drain for testing and operation of shower. (Maximum access distance from hazard is 100 ft (30 m) or 10 sec travel time)
No locking devices are available to supply lines to emergency eye wash stations
Eyewash stations shall have a cleanable trap that will catch sediment located in the water supply pipe between the eyewash station and its shutoff valve
Emergency lighting and/or illuminated escape route signs are required above designated emergency exits
Evacuation Maps and Routes shall be posted in all break areas and office areas
Lighting is at least 30 foot-candles in the processing areas
Emergency evac and severe weather take shelter alarms are audible in all areas of plant
Traffic lights at transfer stations must be visible in any direction

Ladders/Platforms

Needed?
- Yes
- No
All ladders over 20 feet (6100 mm) from the floor must have safety cages and meet OSHA Regulation 29CFR 1910.27. The top of all access ladders shall have a selfclosing gate, or door, or cross bar to prevent accidentally backing off of the platform at the ladder opening. A single run of ladder shall not exceed 30 ft (9144 mm). The space between the ladder and landing shall not exceed 3 inches (75 mm). The top access point of a ladder, if greater than 4 feet above an adjacent surface, shall be equipped with standard railing extending six feet horizontally on either side at a minimum
If a platform is built at a station, it must be made such that the operator is able to be on the platform through the entire sequence of the process. The operator should not have to step off the platform to get parts from logistic racks (steps should be minimized)
All process related stairs shall be painted yellow (contrast in color) along the front and top two inches of each step. Rise to run is acceptable with a mininim width of 22 inches
Stairs 3 risers or less may be equipped with a single handrail. Each situation will need to be evaluated individually to assure hazards present to justify further protection. Stairs greater than 3 risers shall have a standard height handrail
Pinch points shall be minimized by starting platforms in the protected area. This eliminates the pinch point between the platform and the moving body. If this is not possible then the entry side of the platform must have safety devices to guard against pinch points

Hoist/Crane/Overhead Lifting/Transport

Needed?
- Yes
- No
Hoist/crane manufacture's and/or service provider name, address, device serial number, lifter weight (if over 100 lbs)
Hoist and rigging must comply with both ANSI/ASME BTH1 and B30.20, Below the Hook Lifting Devices
All frames and tracks of electrically operated cranes and hoists are grounded
Hoist and lifting device are labeled with load capacity and is visible to operator and both sides of bridge
Facility Engineering approved overhead hoist system
Hoist was designed under supervision of a qualified person
Welding done by a certified welder
Heavy motors allow for maintenance and means for removal
All overhead crane system components are compatible with one another
Hoists are equipped with upper limit switches and gear limit switches
Hoists are designed to limit the drop caused by the loss of pressure or electrical power
Dual action hooks/snap hooks are provided on hoists
All rails, hooks, bridges, hoists, and connectors supporting loads shall be equipped with safety cables or similar redundancy
Safety cables are attached thimble to thimble with saddle on live end of cable
If the support rail has multiple attachment points where redundancy is already built into the system then safety cables may not be required. PE approval is required for these situations
End stops are intact on railing

Lifting Devices

Needed?
- Yes
- No

Vacuum Lifting Devices

Manufacture's or repairer name, address, device serial number, lifter weight (if over 100 lbs), model number, pressure and volume of compressed air, rated load, ASME BTH1 Design Category and Service Class, are all marked on the device
On vacuum lifting device, A minimum of two (2) separate vacuum circuits, with dual patternvacuum cup footprints, in which either side/pattern of the footprints would independently support the part weight/working load, is required. (A separate vacuum circuit for each vacuum cup is preferred.)
Manual shutoffs show on/off position
Danger, warning, caution labels where necessary
Vacuum pad rating method provided
Electrical equipment complies with NEC and NFPA 70
Load rating not more than 80% of the maximum load sustained during load test. Test load not more than 125% of the rated load. Report provided from manufacturer
Welding is done by a certified welder and in accordance with ANSI/AWS14.1
Disconnect provided for externally powered vacuum lifters greater than 120 V AC single phase power source
Correct pump rotation direction verified
On vacuum lifting devices, actual power supply is the same as what is shown on the nameplate
Loss of power shall not result in a hazard (i.e.: Dropping part.) Minimum requirements: The vacuum lifting device shall incorporate a vacuum reservoir system of sufficient size to prevent the vacuum level under the pads from decreasing more that 10% in 4 minutes . Unintended loss of power shall not disconnect the pads from the vacuum reservoir system
On vacuum lifting device, oneway Vacuum Check Valves (to prevent vacuum loss) shall be installed at each vacuum cup location. An individual vacuum gauge is required for each vacuum cup. All vacuum gauges shall be mounted in clear view of the operator (Visible during the use of the assist.). (Note: The “Face” of each vacuum gauge is to be clearly/permanently marked to identify acceptable readings.)
Seals and connections tested for leaks

Close Proximity and Remotely Lifting Magnet

Manufacturer's name, address, lifter's model number, lifting magnet identification number, weight of lifting magnet, duty cycle, cold current amps (at 68degrees F), voltage of primary power, ASME BTH1 Design category, Service Class, rated load (Capacity), application load are marked on device
Rated load of the lifting magnet shall be less than 50% of the rated breakaway force measured in this test
Controls are identified to their functionality (lift, off, drop)
Danger, warning, caution labels where necessary
Control has a device to hold the magnetic circuit in load or release position
Welding is done by a certified welder and in accordance with ANSI/AWS14.1
Electrical equipment complies with NEC and NFPA 70
Control circuit voltage does not exceed 150V for AC or 300V for DC
Controller should have volt and amp indicated
Guarding provided for control in lift position
Device indicating existing battery conditions
Vented housing for wet cell batteries
Audible and visible signal for battery back up
Power disconnects provided
External power inputs is of the correct voltage and amperage, power conductors and controls are of adequate rating and insulated, and protected against damage
Seals and connections tested for leaks

Lift/End Effectors

Manufacture's or repairer name, address, device serial number, lifter weight (if over 100 lbs), model number, pressure and volume of compressed air, rated load, ASME BTH1 Design Category and Service Class, are all marked on the device
Safety cable or redundancy cable must be installed to support lift from falling in case of catastrophic failure of the lift. All vertical support elements must have redundancy
Fastening elements are capable of supporting load and load conditions and must be wired, pinned, use aircraft nuts or some form of fastening that will prevent the loosening of or backing out of the fastener
Lift/end effectors shall be designed to prevent the part picked up to be released unless the part is supported as sensed by the lift assist
A check valve shall be used at any location where accidental air loss would allow a part to fall or be released. They have been checked for functionality and/or damage
Hoist over travel protection is installed, functioning, verified, and includes hardware redundancy
All installations are done in accordance with the manufacturer's instructions
All indicator lights, gages, horns, bells, pointers, etc, are tested for proper function
Controls are identified and positioned to prevent accidental activation
Pinch points are guarded to protect operator
Warning devices are tested
Instruction manual provided, inspection scheduled provided, parts information provided, PM schedule and daily check schedule provided

Structural and Mechanical Lifting Devices (floor mount)

Needed?
- Yes
- No
Manufacture's or service providers name, address, device serial number, lifter weight (if over 100 lbs)
Cold current (amps) are marked on device
Danger, warning, caution labels where necessary
Rated Load marked (if several lifters make up one device all shall have an individual load rating)
ASME BTH1 Design Category selected and marked on device
ASME BTH1 Service Class selected and marked on device
Exposed moving parts are guarded
Welding is done by a certified welder and in accordance with ANSI/AWS14.1
Electrical equipment complies with NEC and NFPA 70
Load rating not more than 80% of the maximum load sustained during load test. Test load not more than 125% of the rated load. Report provided from manufacturer
Modifications performed by manufacturer or qualified third party
Drawing provided from manufacturer
There is a mechanical locking device to secure part
New and reinstalled lifting devices are tested to assure proper operation of latches, stops, limit switches, control devices, vacuum pad seals and lines, magnet in proper working order, and electrical equipment has proper function
All repaired, altered, or modified lifting devices are tested by designated person under the direction of a qualified person
Correct Motor rotation direction verified

Compressed Air

Compressed air nozzles used for cleaning must be reduced to <30 psi (butt end pressure safety nozzles)
Any additional comments and/ or concern please type here
Please attached photos for references of comments and concerns
Inspector Name/Title
Signature

Equipment Installation

Is a designated area defined, ready and scheduled to test the equipment and train employees prior to or at the final installation location? (cGMP, lighting, power, air, dust collection, temp, humidity, etc)
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Where will it take place?
Attach supporting documentation of preparedness (photo, listed requirements)
Does the equipment need moved/installed in it's final location at a later time?
When?
Will the existing equipment/process(es) need modification to accept the new equipment/process?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Is there a need for addition platforms or working surfaces to be constructed/purchased?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Will additional space need to be provided/allocated for materials handling/flow?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Has all required relevant signage been installed on the equipment and surrounding areas affected?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Does the final location/area need any additional identification or outlined areas to designate walkways, safety zones, material storage, etc?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Has all licensing/certification and testing been completed prior to or on installation where required? Calibration certificates available and archived in the proper location for reference?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Cable trays are furnished for electrical wiring where required?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
All cable tray sections are connected and grounded properly? Cable trays shall have a divider between 460 volt and low voltage or communication cable
Who is responsible?
When will it be completed?
Was it completed?
Attach supporting documentation (photo)
Cable trays are covered by stands, platforms, crossovers, etc. in areas that would require regular use of the cable tray for a work surface due to the operation/process, maintenance, etc.? (Note: Cable trays cannot be used as walkways or platforms.)
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Temporary wiring is NOT used for permanent/final destination equipment installations?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Have all electrical wiring and supply utilities been installed according to local/national codes/regulations of the correct type, size and in the correct locations at the point of use?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Incoming power feed terminates at the top of the circuit breaker/disconnect switch with no other connections before this termination?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
If other external power, voltages, controls, interlocks, feeds, etc. are present in the control panel(s), they are clearly marked?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Compressed air lines are kept off the floor and delivered to the proper locations overhead with regulation, filtration and isolation?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Have all equipment/process components & parts been assembled and installed according to the specifications/drawings, and as it was for the FAT?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Have all equipment/process components & parts been assembled, installed/positioned, connected and leveled to the existing equipment/process according to the specifications/drawings in its final location?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Any additional comments and/or concern please type here
Please attached photos for references of comments and concerns

Approval

This equipment has been installed and is ready for testing, verification and training. This section may need to be completed twice if the equipment/activities will take place in two different locations (temporary training area & final installation destination).
Name of Supplier/Manufacture Representative/Project Manager (if on-site)
Signature
Name of Armada Engineering Representative
Signature
Name of Armada Operations Representative
Signature
Name of Armada Quality Representative
Signature
Name of Armada Safety Representative
Signature
Name of Armada Project Manger (if assigned)
Signature
Name of Other Armada Dept Participant (if present)
Signature
Name of Armada Executive
Signature

SAT (Site Acceptance Test) & OQ (Operational Qualification)

Objective

This SAT is a verification that the equipment design and installation meets the User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) within this document. This SAT will accomplish two objectives: Verifying the operation & initial performance of the equipment/process, and to determine the effectiveness of the training of personnel operating, maintaining and cleaning it. This section may need to be completed twice if the equipment/activities will take place in two different locations (temporary training area & final installation location).

Scope

This document is applicable for the equipment & requirements listed on the title page.

Responsibility

Operations personnel operating the equipment will perform their duties as trained. Engineering will attend the event to collect and record the results outlined in this document, then publish the report. Quality, Safety & Maintenance (and other as needed) will also attend to assist and confirm results required for approval.

Requirements

Are machine guarding and emergency stops in place and working as designed? (mechanical & software)
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Are all alarms and visual displays are operational and functioning properly.
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Are external controls, safety interlocks & permissive conditions connected and fully operational?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Where used, there is signals continuity between this equipment/process and other equipment/processes requiring communication? (not safety interlocks)
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Is there any electromagnetic interference (EMI) and compatibility issues with adjacent equipment/processes?
Is it transmission or reception?
How will suppression be accomplished?
Who is responsible?
When will it be completed?
Was it completed?
Is the user interface and the access levels of the operational software set up accordingly with passwords where applicable?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (access list, photo)
Have recipes and parameters (UCL, LCL) been entered into system for Operations to use?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Has 'Power Loss Recovery' testing been performed to verify parameter and recipe settings are not affected?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo)
Has the proper amount and types of materials been made available for the SAT? (same as FAT)
List the requirements
Who is responsible?
What is the target completion date?
Was it completed
Attach supporting documentation
Verification of all components, systems and operation was completed with results the same as or better than the FAT results? (minimum 50pcs; the entire list of test products and final target speed is not necessary)
Attach supporting documentation (Cpk/performance report)
List the failures and the impact on operation, function, or process.
Is there a re-verification required for the poor results?
Who is responsible?
What is the target completion date?
What is the result?
This consideration is included in the ramp-up plan.
What is the justification for the acceptance?
Who approved it?
Attach supporting documentation (Cpk/Performance Report)
This consideration is included in the ramp-up plan.
What is the justification for the acceptance?
Who approved it?
Attach supporting documentation (Cpk/performance report)
Will the new equipment/process cause a work practice and/or supervision change?
List the changes
Has all relevant training been completed prior to/during commissioning?
What is outstanding?
Who is responsible?
What is the target completion date?
Was it completed?
Are staff training records completed and submitted to be properly stored in the database?
Attach supporting documentation (photo, training record)
Visual verification of the employees adjusting/maintaining the equipment according to the manufacture's requirements is adequate enough to accept that their initial training was effective/successful, and they are qualified? (this may take place before or after the SAT)
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo/video)
Visual verification of the employees cleaning/sanitizing the equipment is adequate enough to accept that their training was effective/successful, and they are qualified? (this may take place before or after the SAT)
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo/video)
Visual verification of the employees operating the equipment and performing the process(es) is adequate enough to accept that their training was effective/successful and they are qualified?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo/video)
Will a ramp-up plan need to be developed to allow for this new equipment/process to be fully capable of sustaining or improving the current equipment/process(es)?
Define the plan
Who is responsible?
What is the target completion date?
Attach supporting documentation (Ramp-up Plan)
Has a PM plan been created and scheduled in the CMMS?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo, record)
Is a PM plan and contract for outsourced scheduled maintenance, breakdown or other services required?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (service contract)
Have Maintenance Department personnel received a copy of the equipment binder/documentation package and have they been given an overview of the materials and basic training on pertinent information regarding maintaining and repairing the equipment?
List the requirements
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (photo, training record)
Any additional comments and/or concern please type here
Please attached photos for references of comments and concerns

Approval

This equipment has been tested and approved according to the specifications of Armada Nutrition. After all the signatures are recorded a report will be published.
It is now ready to be released to Operations to begin use.
Name of Supplier/Manufacture Representative/Project Manager (if on-site)
Signature
Name of Armada Engineering Representative
Signature
Name of Armada Operations Representative
Signature
Name of Armada Quality Representative
Signature
Name of Armada Safety Representative
Signature
Name of Armada Project Manger (if assigned)
Signature
Name of Other Armada Dept Participant (if present)
Signature
Name of Armada Executive
Signature

PQ (Performance/Product Qualification)

Objective

To determine that the equipment/system perform as intended by repeatedly running it on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications (URS, FRS ) under normal conditions, and where appropriate for worse case situations.

Scope

To be performed after the Installation and Operational Qualification have been completed and approved. Each piece of equipment must be validated before it serves another piece of equipment/system during validation of the latter. (e.g. water system before steam boiler; steam boiler before steam tunnel, etc.) The PQ will be quantitative measurements of the performance of the new installation at periodic intervals to verify that it, and all associated activities, procedures, processes and personnel are performing as expected. These activities will continue until the targets are reached and the ROI is realized.

Responsibility

Operations personnel operating/maintaining the equipment will perform their duties as trained. Engineering, Quality & Safety will monitor the performance and record the results if necessary.

Procedure

Select all that apply
- Equipment
- System
Qualification of all components, systems and operation during normal running conditions with the first product was completed with results the same as or better than the SAT/IQ results? (minimum 100pcs)
Attach supporting documentation (Cpk/performance report)
List the failures and the impact on operation, function, or process
Is there a re-qualification required for the poor results?
Who is responsible?
What is the target completion date?
What is the result?
This consideration is included in the ramp-up plan.
What is the justification for continuing with the current results?
Who approved it?
Attach supporting documentation (Cpk/Performance Report)
This consideration is included in the ramp-up plan.
What is the justification for continuing with the current results?
Who approved it?
Attach supporting documentation (Cpk/performance report)
Run equipment for the first week and verify all components, systems and operation during normal running conditions still perform as intended. Record all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications (URS, FRS) under normal conditions (with the ramp up plan), and where appropriate for worse case situations.
Attach supporting documentation (Cpk/performance report)
List the failures and the impact on operation, function, or process
Is there a re-qualification and/or additional training required to achieve the expected results?
Who is responsible?
What is the target completion date?
What is the result?
This consideration is included in the ramp-up plan.
What is the justification for continuing with the current results?
Who approved it?
Attach supporting documentation (Cpk/Performance Report)
There are deviations that will allow the targets to be obtained?
What are the deviations and/or new criteria?
What is the justification for the acceptance?
Who approved it?
What is the justification for the acceptance?
The ramp-up plan will be adjusted accordingly?
The ramp-up plan will be adjusted accordingly?
The results will be checked at the next qualification interval and corrective action will be defined if neccessary.
Attach supporting documentation (Cpk/performance report)
After the second week of operation verify all components, systems and operation during normal running conditions still perform as intended. Record all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications (URS, FRS) under normal conditions (with the ramp up plan), and where appropriate for worse case situations.
Attach supporting documentation (Cpk/performance report)
Have the previous issues been resolved?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (Production Report, Work Order, etc.)
Is there a re-qualification and/or additional training required to achieve the expected results?
Who is responsible?
What is the target completion date?
What is the result?
The ramp-up plan has been adjusted based on the new data?
What is the justification for continuing with the current results?
Who approved it?
Attach supporting documentation (Cpk/Performance Report)
There are deviations that will allow the targets to be obtained?
What are the deviations and/or new criteria?
What is the justification for the acceptance?
Who approved it?
What is the justification for the acceptance?
The ramp-up plan will be adjusted accordingly?
The ramp-up plan will be adjusted accordingly?
The results will be checked at the next qualification interval and corrective action will be defined if neccessary.
Attach supporting documentation (Cpk/performance report)
After the third week of operation verify all components, systems and operation during normal running conditions still perform as intended. Record all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications (URS, FRS) under normal conditions (with the ramp up plan), and where appropriate for worse case situations.
Attach supporting documentation (Cpk/performance report)
Have the previous issues been resolved?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (Production Report, Work Order, etc.)
Is there a re-qualification and/or additional training required to achieve the expected results?
Who is responsible?
What is the target completion date?
What is the result?
The ramp-up plan has been adjusted based on the new data?
What is the justification for continuing with the current results?
Who approved it?
Attach supporting documentation (Cpk/Performance Report)
There are deviations that will allow the targets to be obtained?
What are the deviations and/or new criteria?
What is the justification for the acceptance?
Who approved it?
What is the justification for the acceptance?
The ramp-up plan will be adjusted accordingly?
The ramp-up plan will be adjusted accordingly?
The results will be checked at the next qualification interval and corrective action will be defined if neccessary.
Attach supporting documentation (Cpk/performance report)
After the fourth week of operation verify all components, systems and operation during normal running conditions still perform as intended. Record all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications (URS, FRS) under normal conditions (with the ramp up plan), and where appropriate for worse case situations.
Attach supporting documentation (Cpk/performance report)
Have the previous issues been resolved?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (Production Report, Work Order, etc.)
Is there a re-qualification and/or additional training required to achieve the expected results?
Who is responsible?
What is the target completion date?
What is the result?
The ramp-up plan has been adjusted based on the new data?
What is the justification for continuing with the current results?
Who approved it?
Attach supporting documentation (Cpk/Performance Report)
There are deviations that will allow the targets to be obtained?
What are the deviations and/or new criteria?
What is the justification for the acceptance?
Who approved it?
What is the justification for the acceptance?
The ramp-up plan will be adjusted accordingly?
The ramp-up plan will be adjusted accordingly?
The results will be checked at the next qualification interval and corrective action will be defined if neccessary.
Attach supporting documentation (Cpk/performance report)
Was the ramp-up plan sufficient to allow for this new equipment/process to be fully capable of sustaining or improving the current equipment/process?
What is the corrective action?
Who is responsible?
What is the target completion date?
Was it completed?
Attach supporting documentation (Production Report)

Evaluation

Perform all required calculations and statistical analyses for the first month of operation.
Criteria; Attach specifications (URS, FRS)
Results; Attach Validation Report/Production Report
Decision

Approval

This equipment/system has been monitored throughout the ramp-up period to evaluate its performance according to the specifications of Armada Nutrition. After all the signatures are recorded, it will be considered a successful implementation. A report will be published.
Date Qualification Initiated
Date Qualification Completed
Major Observations Made/Problems Encountered
Conclusions on the validity of the equipment/system
Name of Armada Engineering Representative
Signature
Name of Armada Operations Representative
Signature
Name of Armada Quality Representative
Signature
Name of Armada Safety Representative
Signature
Name of Armada Project Manger (if assigned)
Signature
Name of Other Armada Dept Participant (if present)
Signature
Name of Armada Executive
Signature

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Objective

Scope

Responsibility

Requirements

Sanitary

Cleanable to a Microbiological Level

Made of Compatible Materials

Accessible for Inspection, Maintenance, Cleaning & Sanitation

No liquid Collection

Minimize or Eliminate Hollow Areas

No Niches

Operational Performance

Hygienic Design of Electrical Enclosures

Hygienic Compatibility with Other Systems

Validated Cleaning and Sanitizing Protocols

Electro-Mechanical

Electrical

Guarding/Marking

Conveyors/Product Conveying

Safety

Control of Hazardous Energy – Lockout/Tagout (LOTO)

Safety Devices

Emergency Stops (EStops)

Approval

Objective

Scope

Responsibility

Requirements

Pre-FAT -- Factory Acceptance Test Checklist

Factory Acceptance Test Documentation

Factory Acceptance Test Personnel

Factory Acceptance Test Site Preparation (Supplier/Manufacture)

Safety Inspection

Hazard Identification

Ergonomic Assessment

FAT -- Factory Acceptance Test Protocol

FAT -- Performance Test

Post-FAT -- Factory Acceptance Test Follow-up Items

Approval

Objective

Scope

Responsibility

Requirement

Approval

Objective

Scope

Responsibility

Requirements

Documentation & Preparation

Safety -- Facility General Guidelines Inspection

Marking

Guarding

Flooring

PPE/Environment

Ergonomics

Emergency Equipment

Ladders/Platforms

Hoist/Crane/Overhead Lifting/Transport

Lifting Devices

Vacuum Lifting Devices

Close Proximity and Remotely Lifting Magnet

Lift/End Effectors

Structural and Mechanical Lifting Devices (floor mount)

Compressed Air

Equipment Installation

Approval

Objective

Scope

Responsibility

Requirements

Approval

Objective

Scope

Responsibility

Procedure

Evaluation