Tii-3D Solutions
Concept to Reality
3D Scanning
Swiss Machining
3D Printing(FDM/Polyjet)
Reverse Engineering

Validation
Validation is a requirement of the ISO13485 standard, this process is used to validate the performance of a new or changed piece of equipment is in control and meets the specification of the equipment. A validation is also required for vital manufacturing processes that can't be verified by measurment. Apex Consulting will:
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Evaluate processes to determine if a Validation is required.
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Create or revise the validation procedure.
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A validation (IQ/OQ/PQ) will be performed on any manufacturing operation that can not be verified by measurement
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A validation report summarizing pass/fail will be generated
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The validation will be reviewed with management to show the process or equipment passes validation.
Set-up Reduction
Set-up reduction is beneficial to the organization by reducing the number of steps used to set-up and run a specific operation. Set-up reduction will save the organizaion 25-50% time on their set-ups.
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Evaluate the current process in its original state
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Kizan the area to reduce unnecessary clutter
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Determine the tools required for the operation
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Re-evaluate the process to determine time savings
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Summarize changes and document the changes made and the benefits of the time saved
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Review with management and personnel to inform them of the benefits of time saved.
Six Sigma
Six Sigma is a tool used to track a part or process that is out of control and determine the root cause of the process and bring back into control. DMAIC- Define, Measure, Analyze, Improve and Control is a process used to define a problem and bring it back into control. Apex Consulting will:
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Meet with management to determine if a problem really exists and if Six Sigma is really required.
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Evaluate by Six Sigma the out of control part or process.
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Review with management the findings and suggest a solution to control the part or process.
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Make changes to the process
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Review with management to show control of the part and/or the process.
Swiss-Machine Guidance/Training
Swiss machining is a machining process that combines turning and milling into one machine. There is usually a secondary spindle that runs in conjunction with the main to pick off or stabilize the part during the machining operation. The benefits to swiss machining over conventional mill/turn is combining milling and turning into one operation, a guide bushing makes cutting tools at main spindle preventing deflection and tool wear giving a better surface finish and achieving faster cycle times. The sub spindle can also work independently to the main making 2 machines in one. Apex Consulting will:
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Train personnel on time saving ways to set-up a Swiss.
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Train personnel on how swiss machining reduce operations
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Unlock untapped potential by integrating both spindles
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Share program examples and other time saving advice
CAPA
Corrective Action/Preventative Action process is improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations: customer complaint, internal audit, ongoing issue within the organization or personnel makes a recommendation of an issue or idea. Apex Consulting will:
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Evaluate the current CAPA system and procedure to determine the organizations process meets the requirement.
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Meet with management to generate the CAPA and create an action plan if required.
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After data has been gathered for the CAPA response, the findings will be documented.
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If at that time all items within the CAPA has been satisfied it will be closed.
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Close out the CAPA and close out procedures.
Medical Manufacturing Guidance/Training
Medical Manufacturing is a process of machining a single level part to manufacturing a multi level instrument to make up the medical device. Heat treat, polish, lasermark, weld,passivation and assembly are all key components required to build a medical device. Traceability of material and processes as well as outside service processes all must be performed and controlled to build a medical device.
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Meet with management and team to determine the level of guidance and training required.
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Guide and train personnel of the organization in the processes and procedures of device manufacturing
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Assist in the processing and traceability of medical device manufacturing.