Insertion_Tool_Pic_1.jpgIntegration is the key when it comes to maintaining the highest quality manufacturing processes for your injection molded project. This ensures all of the injection molding manufacturing processes are simultaneous and properly controlled for quality, safety, timeliness and accountability.

Management of Quality 

To assure there is a robust Quality System in place ISO 13485 should be mandatory for your injection molder, an FDA registration is highly recommended. This is because it demonstrates that as a supplier:

  • They take their business seriously
  • They are a solid force in the medical device space  
  • They have higher-than-average quality standards  

This robust quality system shows that they monitor the effectiveness of their supply chain. This, of course, is increasingly important as supply chains are consolidated.  It also demonstrates the traceability related to the regulation of materials for when finished devices are in place.

Even though multiple vendors may all be ISO certified, which means following similar quality protocols, there is no guarantee that this data monitoring, collection and storage systems will be compatible.  Correct documentation is critical if quality issues occur or if FDA inquiries are made.  Continuity of data is just as critical as the continuity of engineering or manufacturing processes.  

Injection molding manufacturing engineers are intimately familiar with their manufacturing processes, and understands how to optimize the design to make the most of their equipment and processes - while minimizing manufacturing variability.     Quality needs to be designed into the product based on the capabilities and limitations of the manufacturing equipment and processes.  “Quality can’t be inspected into the product. It needs to be designed and built in.”  States, Thomas Black, VP of B Braun Medical.  

Accountability for Your Injection Molded Product

Another critical aspect requires that all parties involved in the process have the same interpretation of the user requirements and customer specifications. Any engineering team that writes the document one way - while another manufacturing team interprets it differently - could mean a final product that’s inconsistent with the desired function. 

A comparable problem can occur with quality specifications. Measurement capabilities vary from manufacturer to manufacturer. They're using the same equipment, which means it is consistently being calibrated and re-calibrated. The more entities involved in this process, the more unpredictable your outcome.

Working with an integrated contract manufacturer eliminates the need to manage multiple vendors. This means that only one project manager is responsible for the entire timeline from the earliest design stages - through assembly to shipping.   

The development of an integrated project timeline minimizes delays between stages of the manufacturing process. This quickly solves the issue of accountability. With an integrated manufacturer - there is no question about who is responsible for resolving issues.  

Responsive Customer Service

Since large OEM’s continue to consolidate and get larger their demand for customer service increases.  An integrated contract manufacturer helps make this easier by having one company to provide support and feedback which demonstrate value, better collaboration and more proactive responses. 

Vertical Integration of Injection Molding Process

A contract manufacturer that provides sustaining engineering capabilities will be better able to address improvements and changes to the product as feedback returns from the field for proper device operation.

An integrated team can evaluate options from a sustaining standpoint, rather than starting anew. They work as a team to update components and processes without triggering the need to conduct additional audits or validations. 

A vertically integrated contract manufacturer acts as a full extension of your team to provide critical insight and history about everything from material selection - to engineering.  They also have all-inclusive understanding of how and why the product has evolved to the current state.   

Value-added Capabilities

Value Added Capabilities – In addition to creating singular components, an integrated injection molder can provide services that create value for the OEM.  

Additional assembly capabilities, inventory management, testing capability and quality inspection have become standard requirements for injection molders to offer their customers. By partnering with a supplier who can help you save time, resources and money is a key strategy to success. 

 

Building Lasting Relationships - Crescent Industries

Maintaining quality relationships is critical to understanding our customers’ project and expectations. Crescent Industries has been cultivating and continuing relationships based on trust and quality for over 70 years. Our employee-owned and operated company will serve you over the long term and aid in all your injection molded plastic requirements.

Register to  Receive Part  Design Guidelines

Source, Medical Design & Outsourcing Article “5 Tips to Surviving Supplier Consolidation” written by Marissa Fayer.   

Topics: custom injection molding