in an FDA-Regulated Global Business
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 Cork in the Republic or Ireland - overlooking the
The site is on land in Cork Harbour.
DePuy at St Anthony's Road in Leeds UK.
October 2000 and May 2001 Krofire was engaged in building the
Manufacturing aspects of an ERP Model in JDEdwards OneWorld Xe.
DePuy were moving from an AS400 platform base to HP9000 and Unix
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
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.
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.
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.
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