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Manufacturing
Layout, Process Flow, Capability, Optimization, Control and Validation;
Yield, Optimization, Six Sigma, Baldrige Productivity and Profitability
Improvements.
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Streamline a manufacturing process without any major capital
expenditures
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Identify
the fundamental engineering principles which affect process and product
performance by completing statistically valid experiments and a process
capability study
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Establish
optimum process parameters and complete process validation
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Complete
six sigma, baldrige "time and motion" productivity, efficiency
and benchmarking studies
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We have unique
talents and expertise for providing smart solutions to stubborn, chronic
material, process and product problems. Our method is to specify the
expected outcome, isolate the problem, uncover the root cause and fix it
permanently.
We have completed
projects involving fiber optic, blood and body fluid sensors/membranes,
heart valves, pacemakers, blood collection and storage containers, kidney
dialysis, oxygenator and heart/lung bypass devices, syringes, needles,
blades and micro-surgical cutting instruments, sutures,
PTCA-perfusion-fiber optic-central vascular-electrophysiology and suction
catheters, guidewires, micro-catheters and coils, stents, antithrombogenic,
biocompatible, antimicrobial and infection-resistant technologies, dental
and other surgical implants, bone graft plaster formulation, laparoscopic
and incontinence devices, collagen hemostatic and drug transdermal delivery
systems, sterile injectables, hospital waste disposal products, surgical
drains and reservoirs, infection control devices, contact lenses, tortuous
and capillary-pore microfiltration membrane and industrial filtration
systems, gloves, towels and surgical drapes.
We have improved the
performance, quality and cost of many poorly functioning products and
processes through effective redesign, streamlining, statistical process
control, optimization
and defects elimination.
We are thoroughly
knowledgeable about extrusion, injection and compression molding,
thermoforming, cleaning, conditioning, coating, lubricating,
biocompatibility/anticoagulation and antithrombogenicity, conventional and
lyophilized drying, sterilization, packaging, liquid and powder dispensing,
chemical compounding, mixing and handling technologies.
We have successfully
developed, installed, optimized and validated high volume, in-line
processes in manufacturing sites located throughout the US, UK, Puerto Rico
and Mexico.
TechnoBusiness
Solutions(tm) has the required Know-how and expertise for providing
prospective clients with such turnkey manufacturing processes as
these:
1. Needle
manufacturing process from steel sheet stock to finished product.
2. Suture
manufacturing process from steel rod stock to finished product.
3. Blade and other
surgical instruments process from raw materials to finished product.
4. Blood
collection manufacturing process from raw materials to finished product. It
includes glass and plastic test tubes, bags for blood banking, etc.
5. Syringe
manufacturing process from raw materials to finished product.
6. Pre-filled
(with medication) syringe manufacturing process from raw materials to
finished product.
Interested parties
are encouraged to contact us directly for any of the above turnkey
technologies.
The next step will be to establish a lot of
the basic parameters for initiating work on such a project. Such parameters
include establishment of project objectives as well development of the
expected deliverables and associated timetable.
We normally charge a
small consulting fee for preparation of this information for you.
This fee (except any incurred expenses) will be subtracted from the overall
project fees if you were to hire us to help you complete said
project, within 120 days or four (4) months from our submission to you of
said report/proposal.
Said report/proposal
will serve as the concrete foundation for preparation of a realistic and
practical contractual agreement between us.
SOPs - Boilerplate vs. Develop "In-house"
Alternatives
"In-house"
developed SOPs are by far the wise choice versus the boilerplate/cookbook
solution alternative.
Here is a methodology
we have been using successfully since 1980 to develop these SOPs
internally:
1. Establish
quantitatively the user needs (especially the "unmet' user needs) that
a specific group of products, i.e. a product family or product line must
satisfy in order the customer to purchase it and be satisfied with it.
In our experience,
this is the most critical step and most often overlooked or poorly
completed. Therefore, it is like we begin the construction of a new house
with a questionable foundation. Marketing, Engineering, Manufacturing
and Quality functions MUST work harmoniously in order to develop this vital
information THROUGH the customer.
2. Develop a list of
required claims, features, benefits that the product must have in order to
satisfy the user needs of item 1.
3. Develop a list of
required specifications that the product must have in order to satisfy the
conditions of item 2. It is obvious, that a spec. needs to tight when
it must satisfy a critically important user need. Conversely, the opposite
is true as well.
4. Develop your
manufacturing specs. for each of your operations according to the
requirements of item 3. If certain process equipment are not capable
to satisfy one or more of your product's critical requirements, then either
you have to purchase new ones that are capable of doing so or completely
redesign your product so that you can
accomplish this critical
user need with what you got (however, this should be your last resort.)
Overall tip:
All of the above steps are interactive, i.e. a change in one of them can
significantly affect the other ones. There is a need to frequently
review and update these SOPs when changes occur in the customer, incoming
material and manufacturing processes areas. This approach, if followed
correctly is very simple yet very, very powerfully effective.
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