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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:

 

  • Evaluate  processes to determine if a Validation is required.

  • Create or revise the validation procedure.

  • A validation (IQ/OQ/PQ) will be performed on any manufacturing operation that can not be verified by measurement 

  • A validation report summarizing pass/fail will be generated

  • 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.

 

  • Evaluate the current process in its original state

  • Kizan the area to reduce unnecessary clutter

  • Determine the tools required for the operation

  • Re-evaluate the process to determine time savings

  • Summarize changes and document the changes made and the benefits of the time saved

  • 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:

 

  • Meet with management to determine if a problem really exists and if Six Sigma is really required.

  • Evaluate by Six Sigma the out of control part or process.

  • Review with management the findings and suggest a solution to control the part or process.

  • Make changes to the process

  • 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:
 

  • Train personnel on time saving ways to set-up a Swiss.

  • Train personnel on how swiss machining reduce operations

  • Unlock untapped potential by integrating both spindles

  • 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:

 

  • Evaluate the current CAPA system and procedure to determine the organizations process meets the requirement. 

  • Meet with management to generate the CAPA and create an action plan if required. 

  • After data has been gathered for the CAPA response, the findings will be documented. 

  • If at that time all items within the CAPA has been satisfied it will be closed.

  • 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.

 

  • Meet with management and team to determine the level of guidance and training required.

  • Guide and train personnel of the organization in the processes and procedures of device manufacturing

  • Assist in the processing and traceability of medical device manufacturing.

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