- welcome - life sciences user group session # sig8968 1:30 pm – 2:15 pm sunday september 28 th in...

- WELCOME -LIFE SCIENCES USER

GROUP

Session # SIG8968

1:30 pm – 2:15 pm

Sunday September 28th in Room 3001A

Mission Statement

• Who:• The Life Sciences Industry User Group (LSIUG) is a community of Bio-Tech,

Pharma, Medical Device and Diagnostics professionals that are interested in sharing experiences surrounding JD Edwards ERP and related application systems in the life sciences field.

• Mission:• The LSIUG provides a conduit for customers to participate in Oracle JD Edwards

development by providing enhancement requests and use cases for new functionality in JD Edwards software to support the current and future ERP needs of our membership. It is also an opportunity to learn of important Life Science industry applications available from key Oracle partners through presentations and personal meetings.

• Goal:• Work as a community to deliver content to Oracle that is relevant to our industry

and business processes. Everyone is welcome - We need your support to influence future development

Meeting Dates & Times• Face To Face:• COLLABORATE 15 April 12-16, 2015 (Las Vegas, NV)• OpenWorld Sept 28 – Oct 2, 2014 (San Francisco)• In Focus: Dec 2-4, 2014 (Denver)

• Telephone & WebEx:• Jan. 21, 2015

• As needed based on topics• ***************************************************• Toll-Free Access Number: 1-866-696-3376

PIN: 845762• Web meeting Address: https://quest.anywhereconference.com• Web Login Reference: 106203541 • Participant PIN: 845762• Questions: [email protected]• Megan Rae 1-928-864-2823 (direct line)

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mailto:[email protected]

LSIUG Contacts• Lead: Megan Rae [email protected]• Content (at Large): Elizabeth Erickson el

[email protected] • Communications: Barbara Marcks

[email protected]• Oracle Contacts:

• [email protected], [email protected]

• Want to help us influence change? Get involved, we are just asking for a few hours a month or quarter.







Meeting Content: Enhancements• Global Lot Master

• Global Lot Master Enhancement as of 2014-09-21 v2.pptx

• Outbound Inventory (Consignment – Development in process)• LSIUG-MDUG OOW14 Outbound Inventory Overview and Update

_Kara.pptx

• Future Potential Enhancement Topics: • Returns Processing Improvements• High volume transactions & E1 processing• Big Data for Med Device Industry• UDI solution set & GS1 involvement – (solution provided)• Revised RoHS Directive• Others?

Copyright © 2014 Oracle and/or its affiliates. All rights reserved. |

JD Edwards EnterpriseOne Outbound Inventory Management


Update on Outbound Inventory Management

Presented to Distribution Birds of a Feather Group, September 12, 2014Presented to LSIUG-MDUG, September 28, 2014


The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle


Customer

Outbound Inventory ManagementConsigned and Vendor Managed Inventory – aka Supplier Owned & Customer Owned

Planned

Supplier

• Monitor Inventory Availability• Reduce Warehouse Space• Track Financial Ownership• Improve Customer Service

Roadmap subject to change without notice. The above content is for information purposes and may not be incorporated into a contract.


Supplier Owned (Consigned) vs. Customer Owned Inventory

Company Owned Location

Consignment Location

Company Owned Location Customer Location

Non JDE Location

Non JDE Location

•Inventory owned by company•Inventory transactions cause J.E.s



•Inventory owned by customer, zero value to company•Inventory transactions do not cause J.E.s• Inventory has value to customer and must be tracked

Sales Transfer that is recognized as revenue by company, remove inventory from balance sheet, update COGS, etc. Increase VMI location inventory and carry value of inventory at sales price (not cost).

Stock Transfer that is recognized as an inventory move from location to location, but not revenue.

Consumption – deplete inventory, triggers billing

Depletion – causes inventory quantity adjustment, but no J.E.s for company, and inventory has zero value. Not considered a sale or source of revenue.

Customer Owned Process

Supplier Owned Process

Billing – sales order to recognize revenue

Either can be “VMI”


Basic Process

Feature Details

Customer Agreement Contract between supplier (JDE user) and customer, Define ship to locations for customers

Shipment to Customer Supplier ships items to the customer location specified on contract

Consumption Reporting Customer uses items and reports usage to supplier

Replenishment of Items Supplier ships items to customer location (based on consumption)

Billing for Consumption Invoice for consigned goods after consumptionInvoice for VMI goods at time of shipment

One View Reporting Availability information, Average On-Hand, Inventory Turns, Rates of Use for Consigned/VMI,Agreement information, Number of agreements per customer/item/time period, Sales orders for an agreement (average quantities and total quantities)

Planned


Additional Functionality

Feature Details

Mobile (Smartphone and Tablet) Report Consumption, Approve Consumption Reported, Audit Consumption, Return Request,

Business Interfaces Enable EDI to report consumption and update inventory in the customer location. Modify existing Sales BSSVs and RTEs.

Return Requests Enable customer to request a return for an item, approve request & then create RMA

Transfers Move product between customer locations

Console Application Ability to perform all tasks associated to the agreement from one application

Planned


Customer GroupCovering Life Sciences, Industrial, Paper, WD

Copyright © 2014 Oracle and/or its affiliates. All rights reserved. |21

Joel Schipper, Oracle Last updated 21-September-2014

Global Lot MasterHigh Level Requirements Gathering

Life Sciences Industry User Group


The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract.

It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.


• Blue text represents “new” information since the prior update• There are significant consolidations of prior slides within the topics around

– Global mfg– Global lot master– Large number of LSN’s in a Mfg WO– Large number of LSN’s in a Sterile WO

23


Scope and Exclusions• Our focus is on the JDE lot master

– “Serialization” is included for manufactured items where the lot size is a quantity of 1– aka “lot/serial” items in JDE

• Oracle Pedigree & Serialization Mgt– This is the solution for massive numbers of serials assigned after manufacturing –

such as at packaging time for Pharma– Our Oracle contact for that is John Danese

• This has been presented before to the LSIUG.

• A JDE partner needs to integrate OPSM and JDE– There is an existing framework for integration– OPSM is a standalone offering resulting from GS1 initiatives.


Requirement HeadlinesIn this document so far• Manufacturing in multiple countries• Concept of a true global lot master• Special Challenges of Lot/Serialized items• The “other 9” lot dates• Lot security and mass updates• Lots and Case Management

25


Manufacturing in Multiple Countries• A given product can be manufactured in multiple countries– Starts with country of origin field in current lot master – But this field may not be tracked after subsequent transfer

• Testing required

• As lots move among countries, lot date information needs to follow the lot– Some transactions allow a lot to be created at new branch – Date information at the lot level should not be ‘reset’ when the lot is

‘created’ in a new branch following a transfer or a receipt• Sometimes expiration dates are automatically changed upon receipt• Testing required

– Bring along the current lot status code and reason code

26


Manufacturing in Multiple Countries (2)• Edwards Lifesciences customized the movement of lots to bring along

certain lot aspects– Memo lots– Lot/grade code Same lot being processed in different countries

• Examples of other customer modifications?

27


A Global Lot Master with optional lower level Branch/Plant lot masters

• Establish a global lot master using a hierarchal approach– A Global Lot Master based on the F4108– Configuration options to enable B/P level lot masters– Similar to the pricing table and advanced preferences

• Using item/item group preferences• Necessary to override some lot master data in some markets, such as changing expiration dates

– Also similar to the item master and item/branch master• For example: F4108 and F4108BP

• The global lot master contains all data elements– Configure what data can be overrriden at the B/P level


A Lot Master “Ledger File”• Critical to have a “ledger file” to documents each change to the lot

master– Globally and at B/P levels– These are not Accounting changes, but Quality changes

• How much of this is already in the item cardex?– Can everything needed be accessed by adding new lot-only changes to

existing cardex and by using new views/reports?– Testing required

• What changes would require a new ledger file?– Especially when Lot Master “attributes” remain at a master level and should

not change when the lot location changes• E.g., lot status, reason code and all transaction info

– Is this similar to the Fixed Asset history file?– Entries can be global and B/P specific

29


Lot Master Ledger File (2)• The “ledger file” would address shelf life extension– Lot master dates can change globally across all inventory locations.

• The configured hiearchy will control if expirations may vary by location (market) for the same lot

– WL Gore created UBE/reports to go across all branches and keep expiration dates “in sync”• It is necessary to have broad checking programs to find ‘exceptions’ and maintain proper

processes• See also next slide

• Track &Trace still uses the inventory cardex– T&T will need to exit to new lot cardex for qualitative info

• If there is a separate lot master cardex, how would they remain “in sync” with the item cardex?

30


Lot Master Ledger File (3)• Audit file for Lot Master changes

– Interactive application to show changes and details to the global Lot master • Or over the item cardex if all lot data is able to be stored there

• UBE’s over the lot master ledger– Batch application to get the details for the changes in the global lot master ( ability to

see big picture) – Mass hold and release when the Lot status changes– Becky & Rajesh to supply some ‘pictures’ of these

31


Lot/Serialized ItemsSpecial Challenges

• When dealing with large numbers of serialized lots – where the lot quantity is always “one” – there are special challenges:– Global hold and release– Mass movement of massive quantities of serialized lots– Inventory transactions


Lot/Serialized ItemsLarge numbers of serials in a WO• A large number of serial numbers typically are completed in one Work

Order• A work order represents a manufacturing lot

– Typically this lot has been stored in a memo lot field

• Applies to sales orders with many LSN’s– Typically these are SO’s with W-line types (CR Bard)

33


Lot/Serialized ItemsGlobal Hold and Release• While the lots are still in manufacturing, they may need to be released by

each location, or in mass across the globe– Need more description of this release program

• Edwards Lifesciences has a custom batch program to do this– It makes the release at the Global level or at the Branch/plant level– Program can operate on any kind of lot, including lot/serialized lots – do a deeper dive– Mentor did a batch hold/release at the WO & lot level – even with Camstar MES– Gore did a WO completion over multiple LSN’s; similar at Bard – using memo lot field

– process via data collection.


Lot/Serialized ItemsRecommend a DOCO # • Consider the Doc Number (DOCO) as the grouping code for all

related LSN’s – When serial’s are associated to the WO, it creates the DoCo

• Typically this is the manufacturing WO number–But we cannot not lose the original Mfg DOCO

• Need for T&T

–This should be a separate field – not a memo lot #– Same DOCO will be on each related lot/serial lot– DOCO is collected during the transaction to create the lot #

• DOCO is available from all kinds of transactions (sales, WO, Inventory) –This is the ‘parent’ lot # for subsequent transactions–It does not override original Mfg DOCO

– DOCO must be captured in the Lot or Inventory cardex/ledger file

35


SterilizationCrosses many LSN’s and Lots• Typically multiple WO’s are sterilized in the same batch/run

– So sterilization crosses multiple WO’s (that is, lots)– The sterilization step can be within the WO routing because of in-house sterilization– Outside sterilization may be within the routing or in a separate WO– Sterilization lot is also typically held in another memo lot field

• Mfg WO and Sterile WO are different – Sterile groups are bigger than one Mfg WO – may be a license plate

36


Sterilization (2)Crosses many LSN’s and Lots

• WL Gore’s sterile challenges– Can resterilize some items

• Need to track the number of times this has happened–Perhaps use a cat code?– – and this is at the LSN level

• 2 individual LSN’s within a batch have extra sterile passes

• Sterile WO # is an industry need – not just a memo lot – This needs to be a separate field– On resterilization – keep a sterile “counter” field– Separate from a similar counter for the original manufacturing sterilization

“passes” and related sterile lot numbers– The Lot Ledger must track each occurrence of sterilization

37


Sterilization (3)Crosses many LSN’s and Lots• Most of the companies have modifications to cover:

– Mass movement of serialized lots• CR Bard customized using super license plates to move LSN’s

–Using memo 1 for the LPN – same that Tom is using for W&Dispense – slides 11 and 12

–Take a deeper look– Establish expiration date across a range of serialized lots– Handle sterilization of multiple manufacturing work orders containing many serialized

lots• See next slide

38


Track and Trace implicationsLarge numbers of LSN’s

• Allow customers to use memo lots as they wish– Memo lots 1 and 2 are in all inventory trans and all inventory views –

supports beyond life sciences• Tom - Add the DOCO # and Sterilize WO# - and the counter cat code (s) - to other

inventory views that show lots

• Add DOCO # and Sterile Lot # to track & trace– New fields to initiate track & trace searches

• Should eliminate customer modifications around using the 3 memo lots– We should not make requirements dependent upon the use of the memo lot

fields

• Quality groups need to attest to this

39


Lot/Serialized ItemsAll Inventory Transactions• Inventory transaction by “lot” should include all the related serial numbers

– Extends the concept beyond Mfg WO’s to include other inventory & distribution transactions

– IT’s, IA’s, ST/OT’s, Reclassifications - anything that can change a branch– Should we require users to configure which inventory transactions will use a DOCO

# ?

• Supplier lot should be configured as a required field during purchase receipt

• Helpful to have a processing option to require the supplier lot field – companies use Data Collection to enforce this

• Testing required during receipts based upon the flag in item master requiring a supplier lot

40


The other 9 lot dates• WL Gore uses several of these dates, based on type of process, such as

whether– The item is kitted or not– How many sub-assembly lots go into an item

• Current dates within lot master must carry – that is, remain with the lot master – when item moves to another branch plant– Relates to branch-specific lot master

41


Lot security issues• WL Gore has set working with the lot master to be a specific security role– In addition, many mass updates are performed

• Edwards Lifesciences has used row security access, but has also performed some mass updates with special security roles to correct information– They’ll process a heart valve – and need to rework it – giving it a new

completion date in the lot master – which creates a problem in sterilization– Needs to allow user to go in via mass update to correct

• Row security was too difficult• So mass updates are assigned to special security roles• Mass updates eliminate “daily” SQL updates

– Look further at possible systemic causes leading to mass updates


Lots and Case ManagementWL Gore enhancements • Returns and Lot/serial numbers

– A returns center (B/P) collects all returned products– This B/P does not have item/branch records until the first time a product is returned

• Gore automated the setup of these records

– A product can have many LSN’s being returned• Gore automated the setup of related LSN lot masters during/following entry of the RMA doc

–Gore uses a negative PO to receive, and a credit SO to give credit – both need the LSN details

–Shouldn’t this be done within the context of an RMA?

43


Lots and Case ManagementWL Gore enhancements (2)• Copy expiration date from original lot when a lot is returned and a new lot

is created from a rework order– These products are re-sterilized – and this is the source of the requirement for a

counter to track the number of re-sterilizations separately from the number of times it took to originally sterilize after manufacturing

– Note that original sterilization and re-sterilization are different counters

• Restored the “location for receipt” field in RMA entry– Field was closed off in E1 9.0– Fix is to change properties setting on the P400511 Return Material Authorization

Application to enable input.• Oracle will not make this fix (SAR 12574309)

44


Lots and Case ManagementOther potential requirements • Krishna – Covidien is also using Case Mgt relative to Lot/Serials

– Are there any special needs?

45


China and Emerging Markets• Tom and WL Gore report a need to pull newest lots (for maximum shelf

life) rather than the FIFO lot– LIFO is required in certain markets, especially around distributors who demand a

minimum shelf life– Relates to inventory movement of what to locate where– CR Bard uses the grade/potency preference profile to manage minimum shelf life

date

• Tom suggests an advanced preference rule for lot expiry to be ‘more transparent’?– Focus on a different lot date

• WL Gore asks about telling 3PL’s to pick specific lots– Is this within the scope of these requirements?

46


Companies driving Global Lot Master• WL Gore• Edwards Lifesciences• CR Bard• Covidien• J&J/Mentor

47


Next Steps• Oracle Open World LSIUG meeting

– 1:30 to 2:15pm on Sunday September 28– Bring in the Distribution SIG (DMUG) via WebEx because they are not meeting at

OOW• Also covers JD Edwards participants not attending OOW

– Megan to share the Global Lot Master status at OOW– Joel will present an update on the Outbound Invnetory Management project

• Elizabeth Erickson to schedule calls between OOW and INFOCUS to refine requirements

• INFOCUS LSIUG-MDUG joint meeting – December 2-4 in Denver– Finalize Global Lot Master requirements

48

December 2-4, 2014Denver, ColoradoQuestDirect.org/INFOCUS

INFOCUS is the ONLY JD Edwards-exclusive, user-led, user-driven conference.

150+ JD Edwards EnterpriseOne technical and functional education sessions are featured around:- HCM- Financials- Manufacturing and Distribution- Real Estate Industry- Supply Chain- Technology- Upgrades and future release models

Rates increase on November 7! Register now at QuestDirect.org/INFOCUS.

Registration now open!QuestDirect.org/COLLABORATE

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• And more!

April 12-16, 2015Las Vegas, NevadaMandalay Bay Resort and Casino

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Oracle JD Edwards (Functional & Technical)• Added Managed Services Offerings• Added Enterprise Hosting & Cloud Solutions• Oracle Platinum Partner • Headquartered in Denver, CO

Scale and Scope• Government (24+ years) and Commercial (24+ years)• 175+ Consultants / 40+M Sales Revenue• Professional Services (Implementations, Upgrades,

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and as a Company• We help our clients manage change to ensure

mutual business success• Our Mantra is simple:

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our clients business outcomes • Focused on customer satisfaction - “Quality

of the Customer Experience”• SLA’s & Governance-driven in all areas of

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implementations• 21 Net New EnterpriseOne 9.0

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108

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RF-SMART for Oracle’s JD Edwards

Automated Data Collection for Life Sciences

• Work Order Issues• Work Order Completion• Route Steps on WO Tracking• Kanban – 1 & 2 Step

RECEIVING• Receipts by PO• Putaway by Location & Item• Receipt Routing

INVENTORY CONTROL

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- welcome - life sciences user group session # sig8968 1:30 pm – 2:15 pm sunday september 28 th in...

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