DePuy International Ltd - Innovation & Audits

Knowledge Service: ERP Professional Services

Speciality: JDEdwards Manufacturing

Krofire Success in an FDA-Regulated Global Business

DePuy International is part of the Global Johnson & Johnson empire. It Manufactures and supplies medical implants such as artificial Hip & Knee joints amongst other "Trauma" products. The Krofire-supplied Consultant engaged with DePuy (via Unity Enterprises Solutions and our friends at Whitehouse Consultants) across multiple client sites in the UK and Ireland. The engagement began in October 2000 and concluded in late-June 2002. Possible future engagements will involve sites across Europe including multiples in France and one in Switzerland. Krofire demonstrated a number of sophisticated and original solutions in SFDC integration, Subcontract Control, Load Levelling, Audit Trails, WIP/Scrap Accounting and Bar Coding.

DePuy is regulated by the FDA (US Federal Food and Drug Administration). Any part of the Business that may effect the form, fit or function of the medical implants has to meet remarkabley stringent controls. This includes Software Systems such as OneWorld. Validation required strict Documentation regimes and Change Control practices. (The documentation disciplines were a fundamental influence in forming the Krofire WinStream Documentation planning proposition.) FDA requires continual blanket traceability over all changes.

In May 2001 the team moved to Cork in southern Ireland to begin the second phase of the project - the first roll-out to a live site. Cork has a mainly manufacturing site that was a green-field site three years ago. Originally built by J&J the plant was turned over to DePuy as part of J&J restructuring. The young and well educated workforce has been using JDEdwards WorldSoftware for this period, but were limited by an original J&J WorldSoftware model. Krofire faced the challenge of converting a World site to OneWorld Xe to a tight deadline. After a schedule of workshops, conversions, training, gap analysis, configuration, documentation, testing and validation, Go-Live went ahead successfully in early October 2001.

DePuy operate a 'twin cycle' production process: the 'dirty' manufacturing and the Clean Room environments. Part of the Cleansing process involves Subcontractors - of course - with full traceability! This lead Krofire to build a unique Subcontract Control system based upon the 'batching' of multiple Work Orders for shipping. This system extended to advanced solutions and innovations in Purchasing and Production Control. Another Krofire innovation was the 'load-levelling' approach to Capacity Planning which invoked special reports to take standard JDEdwards Planning Data and converting it into Product Family loading which could then be downloaded into spreadsheets for shop loading.

Another innovation was an advanced WIP/Scrap Measurement and Adjustment system.  The solution was to use a Master Business Function usually reserved for a Costed Routing inquiry Screen. A similar solution was also adopted in two other areas to estimate the value of WIP based upon where a Work Order was in the Production life-cycle. The Leeds (UK) site followed with successful Go-Live in May 2002 with ALL of these solutions in place. This included the full integration of two different Shop Floor Data Capture Systems (SFDC) and Bar Coding with OneWorld.