Full Turn-Key Systems

Complete ICON/NISSEI Turn-key Project

1. The project begins with a Project Review Meeting to establish the customer's requirements and needs to produce a product that will meet or exceed their expectations. In this meeting we will establish a solid design strategy to produce the best possible parts, pick the mold shop that will build these molds and establish the molding machine size and automation for this project.

2. Next we will have the tools designed and have a Design Review Meeting in person or via WebEx online. During this meeting our engineers and yours will get together and discuss the tooling designs and make any changes if necessary.

3. When the tooling designs have been approved, the tools will be built. During this process we will monitor all aspects of the tool building process and send weekly reports using Microsoft Project so you can be up to date on the progress of your project. We will also, upon request, send pictures and have special milestone meetings along the way.

4. Towards the completion of the molds we will bring in the Nissei molding machines and customer's support equipment in house with all the set-ups (i.e. shipping, rigging, electrical & water hook-ups)

5. Provide the Water Support by making all the water manifold systems and providing all water hoses with jiffy connectors.

6. Build a Validation Master Plan (VMP), which documents the purpose of the systems, its use, the business process, and the parties responsible for each step of the validation and ongoing use, a scope and limitations to the project and resultant qualification and movement activities. Basically the VMP becomes a document that summarizes the firm's overall philosophy, intentions and approach to be used for establishing performance adequacy.

7. Documentation of the Installation Qualification (IQ), which documents activities pertaining to the proper installation of all equipment involved in the turn-key project. At this stage an IQ protocol and IQ Report will be generated. (Customer to sign off on this report)

8. Documentation of the Operational Qualification (OQ), which documents activities pertaining to the proper operation of all equipment involved in the turn-key project to insure that all the equipment is operating at manufacturer's operating specifications. Establish confidence that process equipment and auxiliary systems are capable of consistently operating within established limits and tolerances. In the OQ the Viscosity Curve will be established, the Process Matrix will be formed and our proprietary 28 Steps procedure will take place. If automation is required it will be added to the OQ validation and be monitored and added to the OQ process parameters. At this stage an OQ protocol and OQ Report will be generated. (Customer to sign off on this report)

9. Documentation of the Performance Qualification (PQ). Establishing confidence through appropriate testing that the finished product produced by our stable process meets or exceeds all quality criteria and dimensional requirements of the customer. In the PQ the Validation runs (K1, K2 & K3) will take place where we monitor the molding process for a set number of hours (usually 4 hrs, 8 hrs, 12 hrs) using different lots of resin for each K-run if available and feasible and then checking critical dimensions each hour of these runs. All complete shots will be inspected each hour of the K-runs and the critical dimensions will be recorded, finally all shots of the K-runs will be gathered, boxed and shipped to customer. Also at this time a tooling capability report and Gage R&R will be generated. At this stage a PQ protocol and PQ Report will be generated. (Customer to sign off on this report)

10. First Article Inspection Report (FAIR). A complete inspection will be done to check that all dimensions of the parts conform to the part print. Also a Process Capability (CPk) will be generated which will shows how close part dimensions on parts checked match the mean dimensions of the part prints.

11. At this time all the Molds, Machines and Support equipment will be shipped to the customer's facility. The customer will be responsible for shipping of all turn-key items from Icon to their facility along with all rigging, electrical and water hook-ups at their facility.

12. When the machines and all support equipment are in place and hooked up and the mold is installed into the press along with all the water, electrical, air and automation, a team from Icon will be dispatched to the customers' facility to start up the molds to the OQ/PQ process. Icon will stay two days to help with start up and training. Any extended training will be quoted accordingly.

13. The documentation supplied by Nissei / Icon Turn-Key program:
  A) IQ Book, which contains all support, documents to properly install all equipment.
  B) IQ Report, which contains Start up Procedures, Steel Certifications, Heat Treat Certifications, Tooling Warranty, Part print and Critical Steel Inspection if required.
  C) All Manuals of Molding machines and Support Equipment.
  D) Nissei / Icon Turn-Key Mold Book.
  E) OQ/PQ Book, which contains all the support documents for the Operation and Performance of the Validation:
    a) OQ/PQ Protocol
    b) OQ/PQ Report
    c) Material Certifications of all the materials and lot to be used in this Validation
    d) Gage R&R Report
    e) Icon Proprietary 28 Step process development
    f) Process Matrix
    g) Viscosity Flow Curve
    h) A complete set of screen shots from the Nissei machine
    i) FAIR Inspection & CPk Report
    j) Part Prints
    k) Customers Quality Criteria
    l) Tooling Capability Report
    m) K1-K2-K3 General Run Info
    n) Validation Requirements Report

14. All orders must be accepted by Nissei America & Icon.

15. This completes the Nissei / Icon Turn-Key program.