Professional Documents
Culture Documents
Quality Assurance Manual
Quality Assurance Manual
Procedures
Advancing modular technology to provide the best way of delivering treatment rooms
Medical Solutions
Veritas Quality Assurance Procedures
2
which may affect shielding attenuation capabilities and scoring, cost evaluations, supply availability and other
manufacturing quality. For example variation in gradation factors. A written purchase order is generated by Veritas’
of materials can significantly affect material density or Purchasing Department that identifies the exact materials
material conformity. and quantities to be delivered to the receiving location(s)
for manufacturing. Suppliers are expected to deliver
Material Sampling and Testing material in truckload quantities for handling and con-
Material samples are to be gathered in accordance with veyance of materials by standard wheel loaders and belt
the “sampling methods” herein and tested at a qualified conveyors. As materials arrive at the plant or receiving
and approved testing lab. The type of tests conducted yard, they are to be accompanied by a Bill of Lading and
on material samples and the reporting are proprietary related paperwork, which further promotes traceability
information of Veritas Medical Solutions. All material back to the original purchase request and specification.
testing is complete in advance of invitation to bid or All Bills of Lading refer to the original purchase order
purchase from approved vendor suppliers. The results date and number and include date and pick-up location
of these tests are to be filed and available for review by of delivered material; tare weight of the product being
Veritas Q/A personnel and physics staff traceable from delivered; name and address of supplier; signature and
time of sampling to procurement and manufacturing in printed name of hauler; and time and date of delivery.
batch lots.
PROCEDURE #3:
Supplier Facilities INITIAL INSPECTION AND MATERIAL HANDLING
It is important in the selection of suppliers to not only
pre-qualify and quantify materials and material availability Receiving, Off-loading, and Inspection
but also facility accommodations. All suppliers must have The receiving party for Veritas must review the Bill of
proper material handling capabilities to adequately fulfill Lading for each load upon its entrance to the facility and
the orders placed by Veritas. This is to include bulk prior to its off-loading, in order to ensure that it is an
handle means, weigh scales - along with a program in approved and pre-ordered material.The off-loading and
place for calibrating and periodic certification of scales, storage of materials is to be in a predetermined location
proper long term storage of materials such that material in a clean holding bin or bin of same material type in
quality will not be adversely affected by weather, settling, current or recent operation. (Note: type, by definition,
or separation from handing, moisture, or oils contamina- means not only chemical or mineral classification but
tion etc. An inspection of supplier facilities is conducted also conformance to the above noted bulk properties
periodically of all approved suppliers and must be of gradation, foreign contamination, bulk density, etc.)
conducted prior to approval of any new suppliers. The Different materials are not to be mixed together for con-
physics and Q/A staff of Veritas must be consulted and an venience of space or other reason unless pre-approved
appropriate supplier site checklist used or drafted for the on a limited and for a specific one-time delivery approval.
intended material needs. In addition to quality of plant
facilities the supplier must conform to basic traceability It is important to note that the simple handling of
guidelines of raw materials as further enumerated in materials can impact the end quality of the manufactured
Veritas Material Suppliers Guidelines. product. Handling should be kept to a minimum and
materials should always be handled in bulk large
PROCEDURE #2: quantities and moved over short distances in preference
RECEIVING MATERIALS to long conveyances and multiple handling occasions.
Excessive handling and conveyance can lead to separa-
Supplier Selection and Delivery tion of materials (especially of premixed to specification)
Upon approval and prior to product purchase, by type or gradation. While methods are to be enacted
material suppliers must review and execute the Veritas to measure such properties just prior to manufacturing,
Confidentiality and Non-Disclosure Agreement. such separations can produce sub-standard product, the
Suppliers are evaluated based on material property removal of which from the process line delays operation.
3
PROCEDURE #4: separation of material constituents or aggregates types,
MATERIAL STORAGE gradations, and sizes. Materials are first transported from
the holding storage bins or casks to gated measuring
Storage of Materials at Veritas Plants or Approved Storage hoppers.These hoppers will subsequently regulate the
Locations amount of materials of each type to be transported by
Materials are stored in accordance with all material safety belt conveyors to the mixing tank. Belt conveyors are
data sheets and supplier recommendations. Bulk materials tested and inspected to ensure that there is no loss of
are to be stored in approved storage bins or protected material throughout the conveyed distance such as
sealed casks as appropriate for material constituents. Any would occur from spillage over the sides of the belts;
liquids are to be placed into leak proof casks with proper back-charge from clutch slippage, tears, or unsupported
ventilators, pumps, hydrostatic gauges, and reservoirs to belt sections. Belt conveyors deliver materials to a
ensure liquids can be delivered in the measured quantity measuring weigh hopper.The weigh scales of the hopper
needed in manufacturing of the VeriShield™ Products. regulate the way in which materials are delivered into
All dry or semi-dry aggregate type materials are to be the hopper by the belt conveyors for the respective
stored in bins or hoppers appropriate for the weights constituents.The weigh scales also regulate the material
and types of materials being stored. While some materi- formulation being produced.When the appropriate
als may be stored outdoors in uncovered bins, all materi- amount of a given material is measured into the hopper,
als are only stored in leak-proof and weather-protected the belt conveyor is signaled to immediately stop and no
hoppers or holding tanks. additional material shall be discharged unless manually
overridden by the plant operations team. Any additional
Storage of materials from various suppliers of same or discharge of materials into the hopper shall be recorded
similar type is separated from each other when feasible. and filed with the batch lot that is being produced.
This segregation procedure ensures traceability to vendor
suppliers’ materials at all times. While it may be impractical to All measured materials (both by weight and volume)
separate every incoming bulk delivery of same supplier/ are recorded for each material batch and lot number.
type material, efforts are made to identify materials deliv- Formulations for materials produced are entered into the
ered over a single purchase order of multiple deliveries. automated batch system program or may be manually
For example, materials from the same supplier and executed by measuring and recording the incorporation
material type delivered over the period of a week or of materials of each type for the product being manufactured.
several weeks may be combined and mixed together so
long as those materials were recorded and checked for PROCEDURE #6:
quality upon each delivery. Bulk materials are immediately TRACEABILITY:
inspected with each truck-load delivery. Inspection consists BATCH AND LOT NUMBER RECORDING
of document review as well as intermittent sampling and
factory testing compliant with benchmark standards. Batch and lot numbers are assigned to every batch and
Once approved, loads may be combined into a single include a time/date stamp or alternate method of
bin or storage cask and presumed homogeneous from recording date and time of manufacture.The quantity
one batch-lot order. of each material constituent is also recorded for each
produced batch and lot. Furthermore, mixing times and
other machine settings are recorded with each batch or
PROCEDURE #5: lot. Mixture times and methods are in strict accordance
MATERIAL TRANSPORTATION with the product manufacturing protocol as under- or
over-mixing may result in poor quality product. Over-
Bulk Transport and Conveyance for Manufacturing mixing may result in material separation/segregation, poor
Operations moisture, or unworkable material flow. Under-mixing may
Materials are conveyed or transported in bulk and over result in non-homogenous material, improper saturation,
as short a distance as practical to eliminate settling and separation and cracking, and other detrimental effects.
4
PROCEDURE #7: finally, they are weighed to check for compliance with
MATERIAL AMALGAMATION weight and density specifications.
Moisture and Admixture Content Each batch is color-coded and segregated, making them
Moisture and other chemical admixtures appropriate to easily-discernible and further promoting traceability.The
the product manufacturing specifications shall be strictly formed product is transported to the curing area, where
monitored to assure best quality product. Prior to adding each individual batch is separately stored for a period of
moisture and admixture, the bulk materials designated for time as prescribed for the specific product.
the lot production must undergo prior testing for inher- Approximately every 20 cubic feet of material is subject
ent moisture. An analysis of retained moisture in the bulk to another round of inspection.
aggregate products is conducted to determine the
amount of additional moisture and admixture content PROCEDURE #10:
appropriate for the batch and lot mixes. Inspection of the PALLETIZING AND FINAL INSPECTION
aggregates for moisture shall be conducted daily at the
start of production. Additional inspection is conducted After the curing period, the blocks are conveyed to
as necessary to ensure proper moisture content.This is the area for palletizing and packaging. At this point,
especially important of materials that are stored out- another representative sample of block are chosen
doors and subject to climate changes that may affect from each batch at random and checked as a cured
moisture content, such as rain and relative humidity. unit for the aforementioned criteria, including dimensional
and weight tolerances, as well as physical appearance
PROCEDURE #8: and characteristics.
VISUAL INSPECTION OF
PREFORMED-POST-MIXED MATERIALS Each and every block is visually inspected before being
palletized. Any block that does not meet the quality
A trained, competent plant operator, familiar with the standard criteria is removed from the line.The remaining
desired material properties, shall conduct a visual inspec- block are then palletized and wrapped. Each product is
tion of each batch mix. Before it is delivered into the wrapped in color-coded materials by product type.While
mold box, the inspector selects a small quantity of mixed there are several ways to visually identify types of block,
material at random.This inspection must include a review they are not always easily differentiated to the untrained
of material consistency, workability, texture, moisture and eye. Color-coded packaging allows for easy identification
homogeneity.This visual inspection is the final step in on the receiving end.
assuring proper material quality prior to entering the
mold manufacturing process. At the discretion of the PROCEDURE #11:
inspector, material may be rejected or modified in order LABELING AND CONTAINERIZATION
to improve any of the aforementioned criteria. Any
changes to the batched materials is clearly recorded and The complete, color-coded wrapped pallets are immedi-
filed with the initial batch data. ately branded with a label that includes a serial number
unique to that pallet.This data is linked to the central
PROCEDURE #9: computer system so that each pallet can be traced to its
BLOCK FORMATION AND INSPECTION original batch and lot.This tracking system provides
detailed manufacturing information for that pallet, including
Material is transported from mixer to manufacturing the day, temperature, characteristics of the day, and how
equipment where the product is formed into a 4-sided much product was made.The pallet may also be affixed a
interlocking block product.Two representative sample label specific to the client. Generally, each batch is labeled
blocks are chosen at random from every batch and are for a specific client during this palletizing process. If a
checked visually for quality of interlocking edges; quality of batch is manufactured for inventory and then sold at a
face dimensions of the units to ensure that they are flat later date, the inventory will be pulled for a specific client
and within the specified tolerances in terms of thickness; and shipped to the respective jobsite.
5
PROCEDURE #12: PROCEDURE #14:
SHIPPING AND DELIVERY INSTALLATION TOLERANCES
Upon being packaged for containerization for shipping, The tolerance for plumbness when building a VeriShield
the pallet and serial numbers are recorded.The container wall is a maximum of 1/2” over 5 coursings of wall
is then sealed to prevent tampering.The product is shielding. Leveling is achieved through the use of a
tracked with a commercial invoice and commercial Bill mortar leveling course every 5th course of wall shielding.
of Lading.The shipment is directly transported from the Mortar leveling bed should not exceed 1/2”.
container port to the job site, at which point it is off- Bearing plate level tolerance should not exceed 1/2”.
loaded into pre-designated areas, usually determined by Any bearing plate level variance is generally based upon
material/type of product. the finish of the steel plate.
Minimum cut size for filler block is 1 1/2”.There is no
maximum size for grout cells or “filler grout”.
PROCEDURE #13:
CREW SELECTION AND SITE SUPERVISION Visual inspections of blocks are performed prior to
block placement. If the visual inspection determines that
Whenever possible, trained crews are contracted to the block has more than 10% mass reduction, then the
install the VeriShield™ product.When a trained crew block is not utilized where the installation drawings call
is not available,Veritas will provide training. A Veritas for a full block. It is important to note that these blocks
representative will also perform periodic site inspections are not discarded. Rather, they are instead fashioned into
to ensure proper installation in accordance with shielding make half-size filler block as well as filler grout..
characteristics as defined by the installation drawings.
Such installation drawings are clearly marked and
differentiate where different product types are to
be used.These drawings are then utilized to install
specific products.
6
Medical Solutions
760 lb. batch 4 1/2 five gallon pails 1 bag 3 to 3 1/2 gal. (11-13 litres)
(3 cu. ft.) (639 lbs. - 289 kg) (94 lbs. - 42 kg) (25 to 29 lbs. - 11-13 kg)
(.08 cu. m)
1500 lb. batch 9 five gallon pails 2 bags 6 3/4 to 7 1/2 gal. (25-28 litres)
(6 cu. ft.) (1278 lbs. - 579 kg) (188 lbs. - 85 kg) (56 to 62 lbs. - 25-28 kg)
(.17 cu. m)
Full bag of V250 1 bulk bag of V250 3 bags 10 to 12 gal. (37 - 45 litres)
aggregate (9.4 cu. ft.) (2,000 lbs. - 907 kg) (282 lbs. - 128 kg) (83 to 100 lbs. - 37-45 kg)
(.27 cu. m)
Storage. VeriShield V250 is unaffected by heat or moisture and can be stored indoors or outdoors.
With respect to portland cement, contact with air and moisture will cause hydration of the cement
and alter the cement properties.The 'shelf life' of typical portland cement is therefore dependent
on the storage conditions. Bagged cement product should be stored off the ground and stacked to
allow free circulation of air. Please note that bags are not waterproof.
Skin Protection: Protective gloves, shoes and protective Steps to Be Taken if Material Is Released or Spilled: Use dry
clothing that are impervious to water should be worn to clean-up methods which do not disperse dust into the air.
avoid contact with skin. Avoid actions that cause dust to become airborn e. Avoid
Eye Protection: Safety glasses with side shields should be inhalation of dust and contact with skin. Wear appropriate
worn as minimum protection. Dust goggles should be personal protective equipment. Scrape up wet materi a l
worn when excessive (visible) dust conditions are present and place in an appropriate container. Allow the materi a l
or anticipated. Contact lenses should not be worn when to “dry” before disposal.
working with this product. Waste Disposal Method: Do not attempt to wash powder
Hygiene: Periodically wash exposed skin with a pH-neutra l or grout down drains. Dispose of waste materials only in
soap. Wash again before eating, drinking, smoking, and accordance with applicable federal, state, and local laws
using toilet facilities. Wash work clothes after each use. If and regulations.
clothing becomes saturated with wet grout, it should be
removed and replaced with clean, dry clothing. NOTICE: Based on research of available data,Veritas
Medical Solutions LLC believes that the information
8. STORAGE AND HANDLING PRECAUTIONS contained in this Material Safety Data Sheet is accurate.
Respirable silica and dust may be generated during pro- The suggested procedures are based on data and experi-
cessing, handling, and storage. The personal protection and ence as of the date of preparation of the MSDS. The
controls identified in Section VII of the MSDS should be suggestions should not be confused with, nor followed in
applied as appropriate. Keep Ve riShield Grout dry until violation of applicable laws, regulations, rules or insurance
used. Do not store or handle near food and beve rages or requirements. Veritas Medical Solutions voluntary prepara-
smoking materials. tion of this MSDS should not be construed, in any way, as
an agreement to be subject to MSHA/OSHA jurisdiction,
9. SPILL, LEAK AND DISPOSAL PRACTICES as applicable.
The personal protection and controls identified in Section
VII of the MSDS should be applied as appropriate.