How One Medical Manufacturer Solved Its Quality Control Challenges

Medical manufacturing company Apple Rubber solves challenges associated with medical quality control and audit reportingThe Manufacturing Challenge:
Apple Rubber Products, Inc. manufacturers rubber components, such as o-rings and seals, for the medical device and aerospace industries. As an AS9100C, ISO 9001 and RoHS compliant manufacturer with a Class 7 (10000) cleanroom, Apple Rubber understands the importance of quality control, full lot traceability, safety and part reliability.

But maintaining a paper-based quality control program with multiple filing systems was creating challenges for Apple Rubber. Because information was stored in many different locations, countless hours were wasted keying duplicate data into separate places, sifting through files cabinets and sending paper documents around to different buildings for approval. Apple Rubber needed a centralized quality system.

The Solution:
Apple Rubber’s manufacturing facilities run on the ERP solution, IQMS. A comprehensive software program, IQMS integrates every aspect of the business, from ERP to MES, MRP, financials, order management, quality, WMS, CRM and more, in one single database.

With IQMS, Apple Rubber was able to migrate all of its quality processes under one centralized system. Because IQMS’ range of quality offerings is robust, Apple Rubber can now manage CARs, MRBs, document control, control plans, PPQ submissions, FMEA, gauge calibrations and SPC analysis all in one place.

The Results:
The benefits of Apple Rubber’s embedded quality management system have been large:

  • Apple Rubber has gained complete visibility and traceability into all aspects of its business
  • The manufacturer has the ability to quickly access all pertinent information related to the part, from the sales order down to the packing slip
  • Rather than chasing paper throughout different buildings for approval, Apple Rubber can now use IQMS’ workflow tools to electronically notify personnel throughout the quality chain
  • Medical customers are able to audit one system, rather than handling audits in separate buildings and offices, greatly reducing the time spent auditing
  • Apple Rubber has had a reduction of IT administrative hours no longer spent updating older, disparate quality programs
  • Apple Rubber gained the ability to drill down in the ERP system to track every aspect of an order, instead of going to multiple filing cabinets where papers were stored
  • With the information all in one place, Apple Rubber can perform much more effective audits and easily show requested information immediately

Apple Rubber performs an average of 15 customer audits a year, with projected increases yearly. Apple Rubber is confident that it can meet that growing demand with little effort. Additionally, Apple Rubber commonly receives complements from its ISO certification auditors for having a quality system integrated with the ERP.

“Apple Rubber offers the simplest to the most complicated rubber part production with one of the highest quality standards, ” said John Tranquilli, materials manager at Apple Rubber Products. “IQMS gives us the ability to have a centralized system to monitor order entry, tool building, live floor production and the quality of the parts being produced – all in one system.”


About Apple Rubber Products, Inc.
Apple Rubber was founded in 1971 in Lancaster, NY, just outside the city of Buffalo. During its 40-plus year history, the company has continually innovated and responded to the changing needs of its customers, introducing unique new products, advancing o-ring and seal material science and developing expert engineering services. Today, Apple Rubber is a leading designer and manufacturer of seals and sealing devices serving the needs of countless industries around the world, from automotive and aerospace to pharmaceutical and medical devices. Apple Rubber offers the seal industry’s broadest range of products with an unparalleled range of services and capabilities to meet your requirements.

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This article was written by
IQMS
Website: IQMS

For more than 25 years, IQMS has been designing and developing manufacturing ERP software for the repetitive, process and discrete industries. Today, IQMS provides a comprehensive real-time ERP software and MES solution to the automotive, medical, packaging, consumer goods and other manufacturing markets. The extended single-database enterprise software solution, EnterpriseIQ, offers a scalable system designed to grow with the client and complete business functionality, including accounting, quality control, supply chain, shop floor, CRM and eBusiness. With offices across North America, Europe and Asia, IQMS serves manufacturers around the world. For more information, please visit iqms.com.